Boston Scientific (Natick, Massachusetts) said in mid-January that U.S. regulators did not clear its initial clinical trial design to test the efficacy of its drug coated stent, delaying the start date of the key TAXUS IV clinical trial. The company was seeking support for its application to begin human trials on its drug-coated coronary stent, which uses paclitaxel to keep the devices from reclogging. Boston Scientific said it would seek approval from the FDA to begin the clinical trial later this quarter, which would allow it to remain on track with its planned launch of the product in late 2003.In December, the company reported that it had been asked to answer some questions surrounding the October investigational device exemption filing for the TAXUS IV, the U.S. trial arm for the stents. At the time, the company had estimated that the setback would probably delay initiation of the trial until January or February.
Analysts who follow the sector said that the delay could handicap Boston Scientific in its race against other companies such as Guidant (Indianapolis, Indiana) and Johnson & Johnson (New Brunswick, New Jersey) to get their coated-stent products to market."Given the change in protocol, we suspect this could delay the start of Boston Scientific's U.S. trial by one or two months," analyst Dan Lamaitre of Merrill Lynch told Reuters news service. "The clear benefactors from this development are Johnson & Johnson and Guidant, as the delay extends their respective clinical leads."
Guidant began enrolling patients in its own U.S. paclitaxel coated stent trial in November, while J&J's Cordis (Miami Lakes, Florida) unit is currently in its follow-up phase.
Boston Scientific acquired worldwide co-exclusive rights from Angiotech Pharmaceuticals (Vancouver, British Columbia) to use paclitaxel to coat its coronary stent products and other vascular and non-vascular products.
Elsewhere in the product pipeline:
Abbott Laboratories (Abbott Park, Illinois) received FDA approval for its Vysis PathVysion HER-2 DNA Probe Kit to detect the HER-2/neu gene in breast cancer patients for use in identifying women with metastatic breast cancer who could benefit from Herceptin therapy. Herceptin, marketed by Genentech (South San Francisco, California), is a targeted monoclonal antibody treatment for women with HER-2 positive metastatic breast cancer. A diagnostic test is required to identify which women are HER-2 positive and candidates for treatment with Herceptin. PathVysion is one of the first examples of genomic disease management for which a direct genetic test enables assessments of patients for determination of the most appropriate therapy based on their genetic profiles. Vysis is a wholly owned subsidiary of Abbott.
Align Technology (Santa Clara, California) was issued three U.S. patents for orthodontic treatment specific to straightening teeth using a series of clear, removable, nearly invisible plastic appliances called aligners, giving the company nine issued patents. Patent No. 6,299,440 covers systems and methods to reposition teeth using aligners to move the root of the tooth first instead of the crown, as is done with wire brackets. No. 6,309,215 relates to using aligners in conjunction with conventional attachment devices mounted onto teeth. No. 6,318,994 covers a computer-implemented system that automatically generates an entire tooth movement plan that details the entire repositioning process for a patient's teeth from beginning to end. Align makes the Invisalign System, a method for treating malocclusion, or the misalignment of teeth.
AMDL (Tustin, California) authorized a study with Dr. Lung-Ji Chang at the University of Florida (Gainesville, Florida) to develop a targeted immunogene therapy for breast cancer using a novel tumor antigen identification approach coupled with the company's immunogene therapy technology. It will first be tested in a breast cancer mouse model. AMDL is a theranostics company involved in the detection and treatment of cancer.
Amersham Health (Princeton, New Jersey), a provider of radiotherapy products, has launched MPOptions, an analytical software tool that helps health care providers better identify, measure and manage the component cost of delivering myocardial perfusion imaging studies to patients. MPOptions was developed by Drs. Timothy Bateman and James Case of Cardiovascular Consultants (St. Louis, Missouri) and Manuel Cerqueira at Georgetown University (Washington), funded by an educational grant from Amersham Health. "MPOptions gives users the ability to model the economic factors of certain practice patterns and provide 'what if' scenarios to explore new methods of delivering nuclear cardiology services in the most efficient and economic manner," Case said. The software provides a means of analyzing costs in a number of categories, including labor, capital equipment, facility, pharmaceutical and supplies.
Biocompatibles (Farnham, England) and British Biotech (Annapolis, Maryland) revealed two milestone events in their collaborative program to develop the Batimastat BiodivYsio stent, a drug-coated device designed to reduce restenosis in patients who have undergone coronary angioplasty. The companies filed an investigational device exemption with the FDA requesting approval to start a pivotal clinical trial (BATMAN II) designed to secure a marketing authorization in the U.S. Additionally, the companies began a pivotal clinical trial (BRILLIANT II) in Europe designed to secure CE mark approval for the stent. The BRILLIANT and BATMAN programs are a series of clinical studies designed to evaluate the safety and efficacy of the stent, which combines Biocompatibles' drug-eluting stent technology with British Biotech's MMP inhibitor, batimastat. Data from the trials will be used to support applications to register the product in Europe and the U.S. BATMAN I is a pilot safety trial under way in Latin America. BATMAN II is a pivotal trial to be run at 40 centers in the U.S. and Canada.
Biomerica (Newport Beach, California) reported that more than 17,000 EZ-Detect tests were purchased as part of a recently concluded colorectal screening campaign in Mississippi in conjunction with Familymeds Pharmacy, which operates 118 pharmacies in 17 states. Biomerica's EZ-Detect screening product requires no handling of stool and has no dietary restrictions. The EZ-Detect pad is tossed into the toilet after a bowel movement. A change in the pad's color to blue/green, which will appear within two minutes, indicates the presence of blood in the stool.
Biocientifica SA (Buenos Aires, Argentina) received CE mark approval for its Diffuplate products. The Diffuplate line is comprised of 25 in vitro diagnostic products to measure proteins in biological fluids by quantitative radial immunodiffusion. These assays can aid in the diagnosis of infectious, autoimmune and nutritional diseases, as well as oncology and coagulation disorders.
Burdette Medical Systems (Champaign, Illinois) released version 2.0 of its interplant Post-implant Analysis Software (iPAS) for assessment of prostate brachytherapy treatment for prostate cancer. The iPAS v2.0 program is used to assess the quality of low-dose, permanent seed implants for prostate cancer, as recently recommended by the American Brachytherapy Society. Using a patented methodology, the iPAS v2.0 locates the exact position of each radioactive seed in 3-D images, rather than the traditional slice-by-slice method used by other programs. The software also offers 3-D views of the prostate, surrounding anatomy, dose distribution, and seed locations for on-screen viewing or printed reports. These images can be viewed from any angle or reconstruction, providing more accessible data for treatment analysis.
Cerus (Concord, California) and Baxter Healthcare (Deerfield, Illinois) initiated the first clinical trial site for their pivotal Phase III trial of the Intercept Red Blood Cell System and received institutional review board approvals at two other clinical trial sites. The Intercept Red Blood Cell System is being developed to protect against transmission of infectious diseases through red blood cell transfusions. The multicenter, double-blind, randomized Phase III protocol is expected to enroll approximately 200 patients requiring acute red blood cell support as a result of cardiac surgery. The acute Phase III protocol is one of two pivotal trials. The second trial will be a 50-patient trial to compare the use of Intercept red blood cells to control red blood cells in support of patients with chronic anemia due to hereditary disorders such as sickle cell disease or thalassemia. Cerus develops medical systems and therapeutics based on its Helinx technology for controlling biological replication.
Computer Motion (Santa Barbara, California), a developer of medical robotic systems, said that surgeons from the Institute of Cardiology (Porto Alegre, Brazil) performed a series of robotically assisted minimally invasive procedures to treat congestive heart failure. The operations used the company's Aesop Robotic Endoscope Positioner through ports in the patient's chest as part of a minimally invasive procedure to insert a biventricular pacemaker electrode into the heart. The biventricular pacemaker stimulates the two main pumping chambers of the heart to work synchronously, permitting an enlarged and weak heart to pump blood to the body more effectively. Additionally, the company said UCLA Medical Center (Los Angeles, California) surgeons performed the first abdominal surgery in southern California using its Zeus robotic system. This is the first time in the U.S. that Zeus was used for this type of laparoscopic surgical procedure, the company said. Zeus is designed for minimally invasive microsurgical procedures.
Cytyc (Boxborough, Massachusetts) submitted a premarket approval application to the FDA for the ThinPrep Imaging System, an interactive computer system designed to assist cytotechnologists in the primary screening and diagnosis of ThinPrep Pap Test slides. The system combines imaging technology to identify diagnostic fields of interest with automated microscope stage movements to facilitate locating these fields. The system is expected to increase a cytology laboratory's screening productivity while leveraging the increased sensitivity of the ThinPrep Pap Test. The application is supported by a prospective, multi-center clinical study of more than 9,500 patients that evaluated the performance of system in direct comparison to a manual review method. In addition, the company submitted a premarket approval application supplement to the FDA to allow testing for Chlamydia trachomatis and Neisseria gonorrhea directly from the ThinPrep Pap Test vial using Roche Diagnostics' (Mannheim, Germany) Cobas Amplicor automated system. Cytyc develops products for medical diagnostic applications primarily focused on women's health.
Digene (Gaithersburg, Maryland) launched the Hybrid Capture ExpressArray Kit, a research assay for gene expression analysis on microarrays. The new kit will enable pharmaceutical and academic researchers to run complex tests involving the study of thousands of genes in a single experiment on DNA microarray platforms, generating quantitative results in hours, compared to two to three days with existing technologies.
Endovasc (Montgomery, Texas) said the U.S. Patent and Trademark Office issued a notice of allowance for its patent application filed in May 1999 covering the use of biodegradable surface coating and method for making same. The technology used in this patent covers Endovasc's stent-coating process called Prostent, which coats vascular stents to prevent restenosis after vascular stenting. The company continues preclinical work on stent coating using two of its clinical products: Liprostin, a liposomal formulation of Prostaglandin E-1, and Nicotine Receptor Agonist, an angiogenic agent.
Fujirebio Diagnostics (formerly Centocor Diagnostics; Malvern, Pennsylvania) will begin marketing a line of six enzyme immunoassays (EIAs) in microtiter format, saying they will be based on the same "gold standard" antibodies used in the Fujirebio Diagnostics Radioimmunoassays. The assays will be available in Southeast Asia in Q102 and later launched in Latin America, the Middle East and Eastern Europe. The assays were co-developed with Trinity Biotech (Dublin, Ireland), an international diagnostics company. The new EIAs will target ovarian cancer (CA 125II), breast cancer (CA15-3), pancreatic cancer (CA19-9), gastric cancer (CA72-4), and prostate cancer (Total PSA and Free PSA). The markers will be available in 96-well microtiter format, using coated microwell strips, to provide laboratories with manual or automated options for greater flexibility.
HealthTronics Surgical Services (Marietta, Georgia) submitted to the FDA an investigational device exemption supplement to the OssaTron device for the treatment of patellar tendinitis, achilles tendinitis and supraspinatus tendinitis. The goal of the supplement is to achieve a general claim for the OssaTron orthopedic shock wave device to treat chronic tendinopathies. The HealthTronics OssaTron orthopedic shock wave device is approved for the treatment of plantar fasciitis, and the company recently submitted a premarket application to the FDA for OssaTron treatment of lateral epicondylitis.
Imaging Diagnostic Systems (Fort Lauderdale, Florida) said the U.S. Patent and Trademark Office awarded patent No. 6,331,700, titled, "Detector Array With Variable Gain Amplifiers for Use in a Laser Imaging Apparatus." This patent protects design aspects of an optical CT scanner, accommodating a huge dynamic range of light intensities emitted from the breast. Imaging Diagnostic received CE marking, UL listing, ISO 9002 certification and FDA export certification, permitting the company to market its product internationally. Additionally, the company received a letter of acceptance from the FDA for Module 1 as part of the premarket approval process for the company's CTLM breast imaging system. Imaging Diagnostic develops a laser-based breast imaging system that uses laser technology and proprietary algorithms to create 3-D, cross-sectional images of the breast.
Imaging Research (St. Catharines, Ontario) released Version 6.0 of AIS, its entry-level image analysis software. The new version features motorized stages, filter wheels and analog and digital cameras. It is compatible with Windows NT and Windows 2000, and is available as a software package or as a complete system for predefined applications such as fluorescence microscopy, quantitative audiography, gel/blot analysis, stereology and automated montaging. Imaging Research, a majority owned subsidiary of Amersham Biosciences (Piscataway, New Jersey), produces analytical imaging and screening systems as well as bioinformatics software.
ImClone Systems (New York) said the FDA is not accepting the company's current rolling biologics license application (BLA) for Erbitux. The BLA was submitted for marketing approval to treat irinotecan-refractory colorectal carcinoma. The company intends to meet with the FDA in order for the filing to be accepted. Erbitux is an investigational monoclonal antibody designed to target and block the Epidermal Growth Factor Receptor, which is expressed on the surface of certain cancer cells. The FDA is reviewing Erbitux for the treatment of colorectal cancer. In February 2001, the FDA granted ImClone a fast-track designation for Erbitux in the treatment of irinotecan-refractory colorectal cancer. ImClone is conducting Phase II and Phase III studies of Erbitux for a number of treatments.
Invivo (Pleasanton, California) said The New England Journal of Medicine published a study on coronary magnetic resonance angiography which could have positive implications for the MRI market served by its wholly owned subsidiary, Invivo Research. This study finds the use of coronary magnetic resonance angiography accurate in the detection of many types of coronary artery disease when compared to X-ray coronary angiography. Invivo said patients "remain still and breathe normally during a coronary magnetic resonance angiography scan. During X-ray coronary angiography, patients are exposed to needles, conscious intravenous sedation, intravenous introduction of contrast agents, radiation, post-procedural pain, possible arterial puncture, lack of mobility and potential risk of infection." Also, MRI scans cost about $700, compared to $5,000 to $6,000 for X-ray coronary angiography.
Jomed NV (Beringen, Switzerland) began two clinical studies on drug-coated stents, PRESENT (PREliminary Safety Evaluation of Nanoporous Tacrolimus eluting stents) and EVIDENT (Endo-Vascular Investigation Determining the Safety of a New Tacrolimus Eluting Stent Graft). PRESENT is a two-armed safety study. One group of patients is treated with Jomed's coronary FlexMaster stents coated with a new nanoporous ceramic coating that has shown anti-restenotic properties in animal studies. The other group receives the drug-eluting version of the ceramic-coated FlexMaster stent carrying a defined dose of Jomed's first-line anti-restenosis drug, Tacrolimus, licensed from Fujisawa Pharmaceuticals Ltd. (Osaka, Japan). EVIDENT evaluates the safety of a tacrolimus-eluting version of Jomed's coronary stent graft, which will be applied for treating patients suffering from saphenous vein graft stenosis.
Lifecore Biomedical (Chaska, Minnesota) reported receiving approval from the Japanese Ministry of Health and Welfare to market the Stage-1 RDS Single Stage TPS Dental Implant System in Japan. The Stage-1 implant represents the first single-stage implant model that Lifecore's Oral Restorative division will be marketing in Japan, with the company saying it expects to expand its Japanese implant offerings with subsequent approvals. The company received approval for the system last September in Korea. The company estimates the Japanese dental implant market at $69.6 million in 2001, growing at more than 12.3%. Titanium Plasma Spray (TPS) coated implants are the dominant style preferred by that country's implant dentists, according to Lifecore.
Life Medical Sciences (Oceanport, New Jersey) received FDA approval to conduct a multicenter, feasibility clinical trial on its Repel-CV bioresorbable adhesion barrier. Repel-CV is designed to reduce the formation of adhesions scar tissue on the surface of the heart after open-heart surgery. The clinical trial will assess the efficacy of Repel-CV in preventing or reducing adhesion formation in neonatal patients who require a staged series of open-heart surgical procedures as well as provide additional data on the product's safety profile. The FDA approval was based, in part, on the favorable results from a multi-center clinical safety study previously conducted on adult patients undergoing open-heart surgical procedures. Life Medical develops a broad range of bioresorbable polymer products to prevent or reduce post-operative adhesion formation.
Magna-Lab (Syosset, New York) reported that Massachusetts General Hospital (Boston, Massachusetts) will begin an animal study of the company's intra-vascular MRI catheter coil. The purpose is to further demonstrate the benefits of using the MRI catheter coil to obtain in vivo, high-resolution MR images of the coronary vessel walls. The product is threaded through a catheter and guidewire to the site of the atherosclerotic blockage. The images are intended to assist in the treatment of coronary artery disease by permitting the physician to assess the morphology (structure and form) and the chemistry of the atherosclerotic plaque, believed by some medical professionals to be a common precursor of heart attack and stroke. The first imaging is expected within the next few weeks, and the study is expected to continue for approximately four months. Magna-Lab develops non- and minimally invasive products designed to make MRI technology more effective in detecting and diagnosing coronary artery disease.
MDX Medical (Vancouver, British Columbia) began beta testing for the 3-D Avid Phantom System-VII prototype at the Mayo Clinic (Jacksonville, Florida) and the Medical College of Virginia Hospitals (Richmond, Virginia). President and CEO David Phillips said the product "enables a 3-D verification of the radiation-dose distributions projected by a treatment plan, in advance of the actual radiosurgical procedure. Its applications go beyond verifying treatment plans to include the commissioning of new radiosurgery equipment, performing routine quality assurance and conducting investigative research and the development of new radiotherapeutic techniques." Alternative technologies presently available either permit only a single-point or 2-D verification or are generally more expensive and require more time. An application for FDA premarket approval is scheduled once design specifications have been finalized.
Medafor (Minneapolis, Minnesota) received FDA clearance to market TraumaDEX, a topical hemostat for the local management of bleeding wounds. TraumaDEX has been cleared as an application for temporary control of severe bleeding in a variety of trauma and post surgical wounds. Bleed-X also has been approved for over-the-counter use for cuts, lacerations and abrasions. Both are based on Medafor's Hemadex technology, a biopolymeric, microporous powder which produces rapid hemostasis in areas of profuse bleeding. TraumaDex and Bleed-X marketing will target emergency medical services, dermatology and over-the-counter industrial first aid markets. Subsequent launches will address military field applications and post-surgical wound management, Medafor said. Hemadex is a hemostatic technology using microporous polymer particles which, when applied to a bleeding wound site, initiate coagulation within seconds. The particles act as molecular sieves to absorb fluids in the blood, attracting and concentrating proteins and platelets and accelerating the natural clotting cascade.
Medtronic (Minneapolis, Minnesota) received FDA approval for its CareLink Monitor and software for remote patient management, allowing physicians to evaluate a patient with an implantable cardiac device over the Internet, without requiring the patient to leave home. The CareLink Network harnesses technology to extend the reach of cardiac patient care far beyond traditional medical practices. CareLink is a medical information system that combines the patient's monitor, a web site for clinicians and a web site for cardiac device patients and their families or caregivers. The product initially will serve patients who have GEM II DR/VR implantable cardioverter-defibrillators (ICDs). However, the network is designed to support a wide range of implanted cardiac devices, including Medtronic's other ICDs, pacemakers, heart failure devices and monitoring/diagnostic devices as they become available following subsequent FDA approvals.
Meridian Bioscience (Cincinnati, Ohio) was granted a patent in Europe covering its technology for detecting the primary causative agent for stomach ulcers, Helicobacter pylori. This technology, which is the basis for the Premier Platinum HpSA test, was granted the first of its U.S. patents in February 1998. Premier Platinum HpSA was the first noninvasive direct test for H. pylori. With current European guidelines recommending a test-and-treat strategy, Meridian said Premier Platinum HpSA will help identify patients that are well suited for treatment to eradicate the bacteria. The HpSA test has proven accurate at both initial diagnosis of infection and at confirming whether eradication therapy has or has not been successful.
Miravant Medical Technologies (Santa Barbara, California) began treating patients in a Phase II trial of PhotoPoint photodynamic therapy for plaque psoriasis, a chronic skin disease in which the immune system triggers accelerated growth of skin cells. The clinical trial is an open-label, drug and light dose-ranging study to assess the safety and efficacy of single topical PhotoPoint treatments. The study targets 54 patients with moderate plaque-type psoriasis who will be treated at multiple U.S. dermatology centers and followed for up to 12 weeks. PhotoPoint uses Miravant's light-activated drug, MV9411, to locally treat psoriatic plaques. The drug is prepared in a topical formulation to penetrate the skin. In the two-step investigational procedure, varying doses of MV9411 are applied directly to plaques followed by a light treatment. This drug completed a Phase I drug-only safety study with healthy volunteers last year. Miravant develops both pharmaceuticals and devices for photoselective medicine.
Misonix (Farmingdale, New York) reported that Hearing Innovations (Tucson, Arizona) received positive preliminary results of its clinical safety and efficacy study of the HiSonic-TRD, tinnitus relief device, conducted at the University at Buffalo's (Buffalo, New York) Speech Language and Hearing Clinic. The study examined 14 subjects who wore the device and reported results over a three-week period. All reported short-term masking relief effects and a significant percentage reported clinically significant long-term relief from their tinnitus, no hearing loss occurred, none reported any extra-auditory effects, and the HiSonic-TRD device did not interfere with the perception of external sounds. Hearing Innovations intends to submit these clinical results to the FDA as part of its 510(k) application. Misonix develops medical, scientific and industrial ultrasonic and air pollution systems and maintains a minority equity position in Hearing Innovations as its exclusive manufacturer of the HiSonic and HiSonic-TRD devices.
Nastech Pharmaceutical (Hauppauge, New York) received FDA clearance to market its noninvasive Mammary Aspiration Specimen Cytology Test (MASCT) device for potential early detection of breast cancer. The company said the device will better enable physicians to detect atypical changes in cells lining the milk ducts — the location where an estimated 95% of all breast cancers originate. Nastech said it anticipates MASCT will eventually become an adjunct to current standards of medical care, including mammography and clinical breast exams. Nastech obtained the product as part of its acquisition of Atossa HealthCare.
Novoste (Norcross, Georgia) said the first two patients were treated in its MOre patency with Beta In the Lower Extremity (MOBILE) trial on Dec. 28 at Rush Presbyterian-St. Luke's Medical Center (Chicago, Illinois). The MOBILE trial protocol will include more than 400 patients from 30 sites in North America and Europe. Patients will be randomized to receive either standard percutaneous catheter-based revascularization therapy followed by vascular brachytherapy or standard therapy alone. Enrollment is expected to be complete in the second half of the year. A female patient had a 32 cm segment treated with the Corona System, while a male patient had a 20 cm segment treated. "We developed the Corona System to deliver Beta vascular brachytherapy to large 5 mm - 8 mm vessels with a short (3 to 5 minute) single treatment time," said David Field, Novoste vice president of new technology.
Ortec International (New York) said its product OrCel was approved by the Centers for Medicare and Medicaid Services for inclusion on the Outpatient Prospective Payment System (OPPS) Pass Through List. Inclusion on the list allows hospitals to recover their cost for OrCel when utilizing the product on a Medicare patient in the hospital outpatient environment. Within the hospital setting, use of OrCel will be reimbursed by the existing diagnosis related groups (DRGs). Ortec obtained two FDA approvals for OrCel in 2001. Marketing activities for the two approved indications, Epidermolysis bullosa and burn donor site wounds, have been initiated and a distribution agreement for these indications will be announced shortly. In addition, a pivotal clinical trial is ongoing in venous leg ulcers and a pilot diabetic foot ulcer trial has recently ended. Ortec is a tissue-engineering company involved in the commercialization of a technology to stimulate the repair and regeneration of human tissue.
Philips Medical Systems (Best, the Netherlands) launched its XRES ultrasound imaging processing technique, which enhances image boundaries and margins while substantially reducing artifacts such as speckle and clutter. Used together with SonoCT Real-time Compound Imaging tissue textures, margins and borders are significantly improved, Philips said. Itx HDI 3000, 3500 and 5000 ultrasound systems are upgradable to XRES technology, with SonoCT imaging as part of the Performance 2002 upgrade.
Prosurg (San Jose, California) received FDA marketing clearance for radiofrequency (RF) gel electrosurgical probes and devices. Prosurg developed the RF gel electrosurgical technology platform for the microinvasive, endoscopic treatment of controlled tissue ablation. RF gel technology represents significant potential for an image guided and controlled tissue ablation treatment of urological, gynecological and general surgical disorders. The conductive RF gel is safe, biocompatible and visible under ultrasound, computed tomography and magnetic resonance imaging during endoscopic procedures. Physicians can create 3-D, interactive RF gel electrodes of any shape and size under real time image guidance to achieve desired tissue ablation zones by controlling the injection volume of the conductive RF gel. The RF gel device consists of an 18-gauge needle probe with a proximal RF connector and delivery port for the conductive gel. The technology can create a larger zone of tissue necrosis compared to conventional RF electrodes.
Qmed (Laurence Harbor, New Jersey) and CHA Health (Lexington, Kentucky) said they have lowered the incidence of heart attack by 35.5% for the total CHA Health membership. In addition, they achieved major reductions in the utilization of invasive and other procedures related to coronary artery disease. QMed president and CEO Michael Cox said, "These total membership outcomes . . . validate yet again the power of our disease management approach that emphasizes the key role of the physician in patient care." Qmed's Ohms CVD (On-Line Health Management System for Cardiovascular Disease) is an information technology that combines patient-specific prognosis and national standard therapeutic recommendations to primary care doctors, while incorporating process reports of expense and health outcomes for the managed care organization. CHA Health is a managed care organization with more than 140,000 members serving central and eastern Kentucky.
Quest Diagnostics (Teterboro, New Jersey) said its test manufacturing unit, Nichols Institute Diagnostics (San Juan Capistrano, California), received FDA clearance to market the Bio-Intact PTH (1-84) diagnostic test kit to measure parathyroid hormone, essential to assess calcium metabolism and bone health. The Bio-Intact PTH test kit is available on the Nichols Advantage platform, a fully automated benchtop chemiluminescence system. The company called the Bio-Intact PTH test the first fully automated, FDA-cleared test to recognize the entire parathyroid hormone molecule, rather than fragments of the molecule, which has a tendency to break up. In recognizing the entire PTH molecule, which consists of an 84-amino acid chain, the Bio-Intact PTH assay has specificity for the N-terminal region of PTH, which is considered essential for the biological effect of PTH. Nichols manufactures specialty immunoassays in the areas of thyroid function, bone and mineral metabolism, reproduction, growth, hypertension, anemia and adrenal/pituitary function.
Radiance Medical Systems (Irvine, California) completed enrollment in the BRITE II (Beta Radiation to Reduce In-Stent Restenosis) pivotal clinical study. A total of 423 patients were enrolled in the study at 26 clinical sites in the U.S. and Europe. The multicenter, randomized BRITE II study was designed to support a pre-market approval filing with the FDA. The study is designed to determine the safety and effectiveness of the RDX Coronary Radiation Delivery System in patients who have had a coronary stent implanted and have returned to the hospital with in-stent restenosis. The follow-up period for these patients is nine months post procedure and is should be completed by 4Q02. Radiance develops radiation delivery catheters for use in the treatment of coronary and peripheral vascular systems to prevent restenosis following the interventional treatment of atherosclerosis.
Radiancy (Orangeburg, New York) said that Health Canada issued a Class II Medical Device License for its new Acne Replacement Kit to the flagship SpaTouch PhotoEpilation System, allowing the company to market ClearTouch acne therapy to new and existing SpaTouch customers in Canada. The kit allows a physician to use Radiancy's Light and Heat Energy (LHE) technology to treat acne without significant side effects or patient downtime. ClearTouch therapy works by aiming an enhanced green wavelength of light and heat over the affected skin, which penetrates the tissue and targets the acne, shrinking the sebaceous glands and destroying acne-causing bacteria. In a recent multicenter study of 60 patients treated with the ClearTouch acne replacement kit, results showed a 70% clearance of acne lesions in 90% of the patients. The 10% of non-responding patients suffered from cystic acne. No complications or adverse side effects were observed. Radiancy is developing medical and aesthetic products using its LHE technology.
St. Jude Medical (Minneapolis, Minnesota) received premarket approval from the FDA for the Atlas family of implantable cardioverter defibrillators (ICD), which the company terms the world's most powerful rate-adaptive ICDs. Atlas ICDs offer high energy and small size without compromising charge times, longevity, or feature set flexibility, the company said. At 42 Joules stored/36 Joules delivered, St. Jude said Atlas ICDs are the most powerful rate-adaptive ICDs available. Atlas is available in two models: a rate-adaptive DR model (V-240) — 37 cc and 12 mm thin; and a rate-adaptive VR model (V-199) — 36 cc and 12 mm thin. Full U.S. commercial release for the Atlas family is scheduled for this month. Atlas marks the third family of rate-adaptive ICDs launched by St. Jude in the past 15 months. Over the next 12 months, the company plans three additional ICD introductions, subject to appropriate regulatory review.
SaluMedica (Atlanta, Georgia) received the CE mark for its Salubria Nerve Cuff, which is intended for peripheral nerve repair. It received FDA approval last October. Classified as a hydrogel, Salubria contains water in similar proportions to human tissue and is similar in its mechanical and physical properties. SaluMedica said the organic, polymer-based biomaterial is soft and compliant like human tissue, and has proven to be exceptionally wear-resistant and strong, "making it an ideal implant, suitable for many medical applications."
ScheduleQuest (Kissimmee, Florida) said the U.S. Patent and Trademark Office approved its application for a patent for its Multi Facility Appointment Scheduling System. This patent, when issued, expands the potential for licensing multi facility scheduling over a variety of market segments. The invention relates generally to scheduling systems and, more particularly, to a multi-facility appointment scheduling system whose implementation and manipulation are handled over global, wide-area, or local-area communications networks. The company also has filed an application with the European Patent Office. ScheduleQuest specializes in Internet-based automated patient scheduling solutions.
Siemens Medical Solutions' Electromedical Systems Division (Danvers, Massachusetts) introduced in the U.S. a comprehensive ventilator platform, Servo i, to bring to the user enhanced levels of clinical performance, cost efficiency and mobility. Servo i uses a single ventilator that can be customized to treat all categories of patients, from neonate, through pediatric, to adult. The product provides tools needed in different treatment methodologies plus a wide range of ventilation modes such as enhanced volume support, SIMV-PRVC and Automode function. The system offers plug-in battery modules, extended options for bedside docking and placement plus patient clinical records that can be fully maintained during transport. Servo i offers a unique holder option to simplify the process of transporting patients. Siemens Medical develops integrated solutions comprising medical devices, information technology and consulting services.
Softshare (Santa Barbara, California) released a Health Insurance Portability and Accountability Act- (HIPAA) compliant mapping suite for its data translation tool, Softshare Delta. The electronic data interchange (EDI) transaction models in this suite incorporate implementation guidelines mandated by HIPAA 1996. Using the HIPAA mapping suite provided by Softshare Delta, health organizations can comply with regulations by converting health care documents such as insurance claims into standardized ANSI X12 formats required by HIPAA. Also, organizations that receive HIPAA transactions can use Softshare Delta to convert those transactions into the formats already used by their internal processing systems for instant integration into their existing operations. Softshare offers a multi-tiered approach to electronic commerce with EDI/XML software solutions that range from desktop applications to fully integrated server applications.
Spacelabs Medical (Redmond, Washington) said the Center for Medicare & Medicaid Services (CMS) issued coverage, billing and claims processing instructions for ambulatory blood pressure monitoring (ABPM) to intermediaries and carriers. These instructions are effective April 1, and on that date ABPM will be covered in accordance with those instructions for Medicare beneficiaries with suspected white coat hypertension. Applicable HCPCS codes have been established and set forth in the revision to section 50-42 to the Medicare Coverage Issues Manual. ABPM helps differentiate patients with true hypertension from those mistakenly labeled as hypertensive based on a few isolated, elevated blood pressure measurements recorded in a physician's office or clinic. CMS has not yet issued a national payment amount for ABPM in its Physician Fee Schedule. Spacelabs works in cardiovascular monitoring, diagnostic instrumentation, clinical information systems and ambulatory blood pressure.
STAAR Surgical (Monrovia, California) said the FDA issued conditional approval for an investigational device (IDE) exemption for the Toric Implantable Contact Lens (TICL). The IDE allows the company to begin clinical investigation on the TICL in the U.S. with patients having myopia in the range of -3.0 to -20.0 diopters and astigmatism in the range of 1.0 to 4.0 diopters. The company said TICL is the only phakic intraocular lens able to both reduce pre-existing astigmatism and provide patients with visual correction for myopia. Enrollment in the primary FDA clinical trial for the ICL for myopia has been completed. In a cohort of 529 cases the incidence of lens opacities was reported to be 2.3% (12 eyes), with eight of these opacities being non-progressive and showing no loss of best-corrected visual acuity. STAAR develops medical devices for use in refractive, cataract and glaucoma surgery.
Stentor (South San Francisco, California) released iSite 3.0, which it calls "the medical industry's most advanced image and information management system." iSite 3.0 includes enhancements to the company's flagship iSite Enterprise image distribution product, and expands to include iSite Radiology, a softcopy diagnosis workstation, and iVault, an online medical image archiving system. iSite 3.0 is based on Stentor's core iSyntax technology, which enables diagnostic quality image distribution anywhere across the enterprise without affecting network speed or image quality.
Steris (Mentor, Ohio) said the U.S. Environmental Protection Agency issued a Crisis Exemption permitting the company to use its ethylene oxide sterilization technologies to decontaminate mail for the purpose of demonstrating safety and efficacy. The company said the exemption is an important step in ensuring that its technologies are available to government agencies and private corporations at risk of receiving mail that is potentially contaminated with disease-producing microorganisms such as anthrax spores. Steris will conduct demonstration studies using its small and medium-sized sterilizers, as well as its contract sterilization chambers, to process letters and other representative articles of mail. The Steris technologies and equipment that will be used are identical to those already proven effective and widely used to sterilize medical products.
Sybase (Dublin, California) released its New Era of Networks Clinical Gateway solution, which uses a standard web browser to provide clinicians immediate and secure access to a consolidated view of data maintained anywhere within the healthcare enterprise. The initial screen displays patient information according to a default search, as specified in the personalized tool for a particular user. The front-end presentation can be customized to fit users' needs. In addition, users can create reports to query the Clinical Data Store.
TheraSense (Alameda, California) said the FDA cleared labeling changes for its FreeStyle Blood Glucose Monitoring System. The changes provide consumers with new information about the use of alternative sites for testing blood glucose. FreeStyle offers less-painful testing, requires the smallest blood sample and allows the broadest array of body sites for testing of any blood glucose monitoring system cleared for marketing by the FDA, according to the company. The specific sites cleared by the FDA include the forearm, thigh, calf, upper arm and hand as well as the fingertip. The FDA permitted TheraSense to continue selling FreeStyle while the revised labeling 510(k) was being considered. Results from numerous clinical studies which were part of TheraSense's clinical data submitted to the FDA are the subject of an article in the fall 2001 issue of Diabetes Technology & Therapeutics.
Thoratec (Pleasanton, California) was notified that the FDA Circulatory System Devices Advisory Panel's review of the company's premarket approval supplement based on the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) trial will occur March 4. The FDA said it would provide an expedited review of the company's PMA supplement application, which seeks approval to expand the intended use of the HeartMate VE LVAS (left ventricular assist system), based on the results of the REMATCH trial. If approved, the device would be available to provide long-term support for end-stage heart failure patients not eligible for heart transplantations. The device currently is approved for use as a bridge to heart transplant. Results released at last November's annual meeting of the American Heart Association (Dallas, Texas) demonstrated clinically meaningful survival benefits and improved quality of life for end-stage congestive heart failure patients supported by the HeartMate VE. Thoratec also received FDA approval of a supplement to its approved investigational device exemption that enables the company to begin Phase II trials for its Aria CABG (coronary artery bypass graft). The trial is designed to test the safety and effectiveness of the device in coronary artery bypass surgery patients who have too few or no suitable vessels of their own. Phase II will expand enrollment up to a total of 110 patients in up to 20 centers from the 20 patients and six centers in Phase I.
Vascular Architects (San Jose, California) received FDA 510(k) clearance to market the next-generation aSpire Covered Stent and Controlled Expansion Delivery System for use in treating tracheobronchial strictures. The aSpire Covered Stent is a spiral nitinol stent completely covered by a thin layer of ePTFE, which the company said provides greater lumen wall coverage than metallic stents, with no exposed metal. The stent is available in lengths of 2.5 cm, 5 cm and 10 cm, and in diameters from 6 mm to 12 mm. It is delivered using the company's Controlled Expansion delivery system, now available in a lower profile, with either 50 cm or 100 cm shafts, and is compatible with a .035 inch guidewire. The aSpire stent is being clinically evaluated in the U.S. under two investigational device exemptions for treatment of iliac and superficial femoral artery occlusions and of dysfunctional arterio-venous access grafts.
Vasomedical (Westbury, New York) reported positive results of a study published in the December 2001 issue of Cardiology. The trial studied 1,957 coronary artery disease patients, including a cohort of 548 patients with a history of congestive heart failure (CHF), enrolled in the International EECP Patient Registry (IEPR) who underwent EECP enhanced external counterpulsation. The study, titled "Benefit and Safety of Enhanced External Counterpulsation in Treating Coronary Artery Disease Patients with a History of Congestive Heart Failure," revealed that nearly 70% of patients, both with and without a history of CHF, experienced an improvement in their functional angina class with fewer anginal attacks and reported an improved quality of life. Also, a subgroup analysis of patients with a history of CHF and severe left ventricular dysfunction revealed similar benefits to those with less severe left ventricular dysfunction after EECP treatment. Vasomedical is primarily engaged in enhanced external counterpulsation systems based on its technology currently indicated for use in cases of angina, cardiogenic shock and acute myocardial infarction.
VSM MedTech (Vancouver, British Columbia) received the CE mark for its BpTRU automated, noninvasive blood pressure monitor. The company is establishing a network of European distributors to implement its sales strategy for this market. With one-touch operation, the BpTRU Model BPM-100 automatically records blood pressure, providing hospital-grade accuracy. It has been designed to replace aneroid and mercury sphygmomanometers, technology that dates back more than 100 years. VSM MedTech's noninvasive solutions include applications for the accurate measurement of blood pressure in both primary and acute-care health care environments and imaging systems for the assessment of adult and fetal brain function.
World Heart (Ottawa, Ontario) was granted an import license for its Novacor LVAS (left ventricular assist system) in Japan. The company said Novacor is the only implantable ventricular assist device to receive an import license in Japan, completing the process necessary for commercial sales. Novacor is distributed exclusively in Japan by Edwards Lifesciences (Irvine, California), which operates there as a joint venture entity with an affiliate of Baxter International (Deerfield, Illinois). Novacor is an implantable, pulsatile pump that takes over most of the natural heart's pumping function and delivers blood to the body, responding to the demands of the recipient's physiological state. The system includes an externally worn controller and rechargeable battery packs that allow the recipient to be discharged from the hospital and resume most normal activities. The system was approved for sale in Europe in 1994 without restriction, in the U.S. in 1998 and later in other countries as a bridge to transplantation.
X Technologies (Tustin, California) received FDA approval to proceed with a pivotal clinical study of the FX miniRail Coronary Dilatation Catheter. The multicenter study is designed to evaluate the safety and clinical effectiveness of the product for dilating coronary stenoses and improving myocardial perfusion. The study is being conducted at nine centers in the U.S. and Europe. X Technologies received CE mark approval for the FX miniRail device in December, with European launch of the product now under way. The FX miniRail is a 6 Fr-compatible system integrating two flexible stainless steel wires adjacent to the dilatation balloon. These wires focus the balloon's dilatation force to create two longitudinal expansion planes in the coronary plaque and stabilize the balloon across the target lesion. The device has a 12 mm guide wire exit port that facilitates rapid, single operator exchanges.
Zassi Medical Evolutions (Fernandina Beach, Florida) said the U.S. Patent and Trademark Office has notified the company of allowable claims on its divisional patent application of the previously issued patent No. 6,033,390, issued in March 2000 for a Continent Ostomy Port (COP). The new patent expands the protection of the Continent Ostomy Port's moisture barrier and its functional interface with the COP. Zassi said the Continent Ostomy Port System currently under development is intended to restore bowel control to those who have been rendered incontinent due to ostomy surgery. The system is designed to allow individuals with ostomies to manage themselves without the need for external collection appliances. Zassi said the Continent Ostomy Port System is licensed to ConvaTec (Skillman, New Jersey), a division of Bristol-Myers Squibb, for sales, marketing and distribution.