Surgi-Vision (Baltimore, Maryland) launched its Intercept product line of internal magnetic resonance micro-coils at last month's Radiological Society of North America annual meeting in Chicago, Illinois. The two products were the Intercept-Esophagus and the Intercept-Urethra, both of which recently received marketing clearance from the FDA.
The Intercept micro-coils, similar in size to standard catheters, are used in conjunction with existing magnetic resonance imaging (MRI) machines to produce high-resolution images from inside the body. Through internal imaging, physicians eliminate the surface interference characteristic of traditional MRI. The detailed images produced by the Intercept micro-coils can be viewed at any angle and in any 3-D plane, enhancing the ability to detect lesions and tumors and to differentiate between healthy and diseased tissue. The company says it is the only U.S. manufacturer offering internal micro imaging coil technology cleared by the FDA.
The Surgi-Vision Intercept-Esophagus produces high-resolution images of the esophagus and aorta. The micro-coil is passed into the esophagus through the nose during the MRI exam to produce highly detailed views of the esophageal wall that may prove invaluable in the early detection of esophageal cancer. Views of the adjacent aorta can reveal microscopic plaques that are early indicators of heart disease and stroke. The Surgi-Vision Intercept-Urethra, similar in size to urology catheters, is placed in the urethra following a standard MRI exam to produce images of nearly microscopic detail. These images may aid in the detection of diseases of the female urinary tract including incontinence.
Surgi-Vision said it expects to introduce several additional micro-coils soon, having submitted 510(k) applications with the FDA for the Intercept-Prostate and the Intercept-Vascular micro-coils.
Elsewhere in the product pipeline:
ADM Tronics (Northvale, New Jersey) has been granted a U.S. patent on a noninvasive medical device for treating neuro-cerebral disorders, such as multiple sclerosis and Parkinson's disease. The patent, titled "Corona Discharge Beam Treatment of Neuro-Cerebral Disorders," further covers a therapeutic electronic medical device that noninvasively treats a patient's neuro-cerebral condition with a pulsatory corona discharge of a complex electronic energy signal. ADM Tronics makes noninvasive electronic medical devices, chemical products and topical dermatological products.
Advanced Bionics (Sylmar, California), the only U.S. maker of bionic ear implants, has received approval from the FDA for use of its Clarion HiFocus Electrode in children as young as 18 months (children 12 to 17 months of age can be implanted under clinical investigation). The HiFocus Electrode is the component of the Clarion cochlear implant that is surgically implanted into the inner ear, and may now be used to treat hearing impairment in deaf children. Advanced Bionics owns eight patents covering the third-generation HiFocus Electrode and all second-generation cochlear implant electrode technologies (the precurved spiral electrode and the precurved contoured electrode with stylet).
Artimplant (Stockholm, Sweden) has received a U.S. patent for its principal product. The patent refers to all implant products based on linear block polymers containing urea and urethane groups. Artimplant makes biodegradable implants with the aim of recreating an active life.
Boston Scientific (Natick, Massachusetts) reported FDA clearance of two stent products for the treatment of malignant obstructions associated with gastrointestinal diseases. The Unistep Plus Wallstent Enteral Endoprosthesis is cleared for relief of malignant obstructions of the colon and duodenum as well as a bridge to surgery – an alternative to temporary surgical colostomies associated with malignant colonic strictures. The Unistep Plus Permalume Covered Biliary Wallstent is cleared for palliating malignant obstructions of the bile duct. Both products are available from the company's gastrointestinal endoscopy division, Boston Scientific/Microvasive. The Unistep Plus Wallstent Enteral Endoprosthesis is the only product cleared by the FDA for both duodenal and colonic indications. The system features a new delivery method using a braided outer catheter that allows the stent to be repositioned prior to deployment. It is currently available in the U.S., Europe, Canada and Australia. According to the company, the Unistep Plus Permalume Covered Biliary Wallstent is the first commercially available covered metal biliary stent. Its new stent covering may reduce tissue in-growth that leads to the incidence of premature stent occlusion. The company says this could minimize complications and reduce the likelihood of additional interventions. The Covered Biliary Wallstent is currently available in the U.S., Europe, Canada and Australia. Japanese market approval is expected soon.
Caliper Technologies (Mountain View, California) has been issued five new U.S. patents that cover microfluidic technology and expand Caliper's proprietary position in high-throughput experimentation in microfluidic chips. U.S. patent 6,150,180, titled "High throughput screening assay systems in microscale fluidic devices," covers multiplexed methods and chips used in Caliper's LabChip high-throughput screening applications that support parallel experimentation at extremely high throughput. U.S. patent 6,150,119, titled "Optimized high-throughput analytical system," covers broad algorithms for optimizing design of channels in chips to facilitate continuous, serial processing experiments. U.S. patents 6,149,787, titled "External material accessing systems and methods" and 6,148,508, titled "Method of making a capillary for electrokinetic transport of materials," cover methods that pertain to the company's chip technology. The first patent covers variations on sipper chip formats and sampling methods, and the second patent covers improved fabrication methods. U.S. patent 6,149,870, titled "Apparatus for in situ concentration and/or dilution of materials in microfluidic systems," covers the performance of dilution in microfluidic chips. This patent covers methods for achieving high accuracy, serial dilutions up to many orders of magnitude in microfluidic systems, and is a critical aspect of performing chemical and biochemical experiments.
Cerus (Concord, California) received a U.S. patent relating to the company's proprietary method for inactivating viruses, bacteria and other pathogens in compositions containing red blood cells. The patent, No. 6,143,490, covers methods for using specific types of chemical compounds that bind DNA or RNA of pathogens to block their replication. The technology currently is being applied in the company's Intercept Red Blood Cell System, which is being developed jointly with Baxter Healthcare (Deerfield, Illinois). Cerus is developing medical systems and therapeutics based on its Helinx technology for targeting DNA and RNA to control biological replication. Its most advanced programs involve systems to enhance the safety of the world's blood supply.
Medical robotics company Computer Motion (Goleta, California) reported that two surgeons from L'Institut Mutualiste Montsouris (Paris) have performed the world's first series of robotically assisted sympathetomy procedures to surgically treat palmar hyperhidrosis, or "sweaty palm syndrome." In this minimally invasive procedure, the surgeon severs the sympathetic trunk inside the thorax between the second and fourth sympathetic ganglions using Computer Motion's Zeus system. The company developed the Evolve Surgical Continuum to facilitate a pathway for surgical teams to become familiarized with robotics in their standard minimally invasive techniques, which will lead them to new minimally invasive procedures with the Zeus Robotic Surgical System. Computer Motion has completed an FDA-approved Phase I investigational device exemption (IDE) coronary bypass study and has initiated an IDE mitral valve surgery and general laparoscopic studies with the Zeus System.
Cook (Bloomington, Indiana) will begin investigational use of its new Logic Coronary Stent in clinical trials later this year under an IDE approved by the FDA. The clinical trial will include 400 patients receiving the Logic stent for de novo lesions and 300 patients who will receive the Logic stent for acute and threatened vessel closure. Cook has received permission to conduct the non-randomized trial at 15 investigational sites. Data on the clinical efficacy and safety of the Logic Coronary Stent collected during the trials will form the basis of Cook's future premarket approval application to the FDA to market the device in the U.S. This stent is indicated for use in patients with symptomatic ischemic heart disease due to de novo lesions shorter than 15 mm in native coronary arteries with a reference vessel diameter ranging from 3.0 mm to 4.0 mm and is intended to improve lumen diameter. Additional indications include treatment of acute or threatened closure in patients with failed interventional therapy in vessels with reference diameters in the range of 2.3 mm to 5.0 mm and lesions less than 40 mm in length.
C.R. Bard (Murray Hill, New Jersey) has received FDA approval to market the Bard Stinger Ablation Catheter for the treatment of cardiac arrhythmias. Ablation catheters are used to eliminate short circuits in the heart tissue that cause the heart to beat rapidly. This is accomplished by applying radiofrequency (RF) energy through the catheter directly to the tissue of the heart to destroy the circuit(s) causing the problem. The Stinger ablation catheter provides features and capabilities that enhance controlled endocardial ablation.
CryoCath Technologies (Kirkland, Quebec, Canada) a maker of catheter cryotherapy systems, has begun enrollment for its feasibility study for the treatment of supraventricular tachycardia and focal atrial fibrillation, using its new 7 Fr Freezor cryocatheter ablation system. The study will enroll 60 patients over the next several months at three Canadian clinical sites: the Montreal Heart Institute, the Ottawa Heart Institute and the London Health Sciences Center. The new system has been developed to improve upon the first-generation 9 Fr Freezor product. The new system uses an improved refrigeration technology that can potentially deliver up to 40% more cooling power inside a beating heart, providing effective performance in virtually all blood flow situations, according to the company.
CryoLife (Kennesaw, Georgia), maker of living human tissue implantable devices and a manufacturer and distributor of stentless heart valves and surgical adhesives, said it has filed an investigational device exemption application with the FDA for use of its BioGlue Surgical Adhesive in all pulmonary surgical repairs. The BioGlue clinical study is expected to be conducted at up to 10 medical centers and involve about 100 patients. BioGlue is approved for vascular and pulmonary repair in 41 foreign countries and is commercially available in the U.S. under a FDA-approved humanitarian device exemption for use as an adjunct in the repair of acute thoracic aortic dissections.
CTI (Knoxville, Tennessee) has received clearance from the FDA to market its ECAT Accel diagnostic imaging scanner, which the company says uses a new detector crystal to provide better resolution than currently available positron emission tomography scanners, enable physicians to precisely monitor the efficacy and side effects of chemotherapy drugs, and reduce scanning time from 40 minutes to 20 minutes. This scanner uses lutetium oxyortho-silicate, a new crystal material with high-energy imaging characteristics to improve patient throughput while maintaining image quality for oncology and cardiology indications.
Eclipse Surgical Technologies (Sunnyvale, California) said that the results of a 13-site, randomized clinical trial showing the benefits of its newest laser heart procedure were published for the first time in a peer-reviewed journal, The Lancet. The trial, which assessed the safety and efficacy of the minimally invasive procedure over a 12-month period, showed that it could substantially relieve chest pain and improve the quality of life for selected patients with coronary disease. The procedure, called percutaneous transmyocardial revascularization (PTMR), is a catheter-based therapy for patients with angina, for which bypass surgery or angioplasty are not possible. A total of 221 patients with inadequate blood flow to the heart caused by blocked blood vessels, a common cause of angina, took part in the trial, dubbed the Potential Angina Class Improvement for Intramyocardial Channels (PACIFIC) study. Ninety-two of the patients, selected at random, were given the PTMR procedure and then given an exercise tolerance test 12 months later. Their test results were substantially better than the results of the other group, given regular medical treatment for 12 months but no PTMR. A total of 34% of those who had the PTMR procedure also experienced a significant lessening in angina, compared to only 13% of the other group. During the PTMR procedure, a physician makes a small puncture near the patient's groin and steers a catheter through a blood vessel inside the heart. Once there, a laser creates tiny channels in the heart muscle with impulses that ultimately promote better blood flow and lead to cardiac angiogenesis.
EDAP TMS (Vaulx-En-Velin, France) has filed a submission to obtain a 510(k) approval with the FDA for its Sonolith Praktis Lithotriptor. EDAP TMS makes minimally invasive medical devices primarily for the treatment of urological diseases.
Enteric Products (EPI; Westbury, New York), a wholly-owned subsidiary of E-Z-EM, has received FDA clearance for a new test for Helicobacter pylori, a bacterial infection that is the leading cause of peptic ulcer disease. The test, which detects H. pylori IgA antibodies, is, according to the company, the first of its kind. The new PP-CAP IgA enzyme immunoassay (EIA) kit was cleared by the FDA in November. The product is an in vitro qualitative test for the detection of IgA antibodies to H. pylori in human serum or plasma. The test assay is to be used as a second-line test in the diagnosis of infection for H. pylori in adults with symptoms suggestive of gastrointestinal disease but who may have tested negative for IgG antibodies to the bacterium.
The FDA has accepted for filing EP MedSystems' (EPMD; Mount Arlington, New Jersey) premarket approval application for its Alert catheter. EPMD expects the PMA review to be completed in early 2001. The Alert catheter is used in tandem with the Alert Companion to deliver a bi-phasic low energy waveform used to convert atrial fibrillation to a normal heart rhythm. The Alert System has been shown to use about 50 times less energy for cardioversion than the standard external paddles.
Galil Medical (Woburn, Massachusetts) has been awarded a U.S. Patent for its SeedNet technology. SeedNet is a minimally invasive, high precision cryosurgical method and apparatus for treatment of prostate cancer. The new patent features high-resolution cryoablation through the use of a number of very thin cryoneedles that provide what the company terms "accurate conformance" to the shape of the tumor while minimizing the negative effects of the process on adjacent healthy tissue. The patent also features the use of an insertion template that corresponds to a guiding grid on the screen of a 3-D image for placement of the cryoneedles.
Guidant (Indianapolis, Indiana) said the first human implants of its Multi-Link Penta coronary stent were performed by Thomas McGarry, MD, of the Oklahoma Foundation for Cardiovascular Research (Oklahoma City, Oklahoma). Guidant's Multi-Link Penta clinical study will enroll 200 patients at 22 sites throughout the U.S. and Europe. Guidant said the Multi-Link Penta system features the best attributes of its original ACS Multi-Link and recently launched Multi-Link Tetra coronary stent system designs. The system features V.T.S. (Variable Thickness Strut) technology, which allows flexibility, conformability, scaffolding and radiopacity in one stent design. The V.T.S. technology varies the thickness of the struts in certain areas of the stent to provide radiopacity and thinner in the areas that provide flexibility and conformability. It also features the GRIP stent crimping process, which delivers enhanced stent retention and smooth surface transitions across the stent and delivery system, along with the S.T.E.P (Short Transitional Edge Protection) technology, designed to minimize the amount of vessel dilated outside of the stent.
Nidek (Gamagori, Japan), a manufacturer of ophthalmic and optical equipment, was issued a U.S. patent for the refractive correction of astigmatisms via bitoric ablation. Specifically, Nidek's patent covers refractive correction of monogenic myopic astigmatism and compound astigmatism (bi-toric astigmatic correction). Dr. Arturo Chayet of Tijuana, Mexico, was named as the inventor of this new method, which he developed using Nidek's excimer laser technology. Chayet's method enables varied tissue ablation, which will address astigmatic corrections in addition to either hyperopia (farsightedness) or myopia (nearsightedness). According to the company, this new method reduces the amount of corneal tissue removed, facilitating more precise laser vision correction of astigmatic corneas and results in better patient vision outcomes.
A pathogen inactivation technology developed by Pall (East Hills, New York) that the company says potentially can safeguard the blood supply from bacterial and viral contaminants successfully completed a Phase I clinical trial. The Inactine Pathogen Inactivation Technology has progressed to a Phase II clinical trial, and Pall is collaborating with V.I. Technologies (Watertown, Massachusetts) to be the first to commercialize pathogen inactivation technology for red cells, the most frequently transfused blood component. The Phase I clinical trial investigated the 24-hour recovery and survival of Inactine-treated red blood cells in human subjects. The study found that Inactine-treated red blood cells are viable after 28 days of storage.
Pyxis (San Diego, California), a subsidiary of Cardinal Health (Dublin, Ohio), has introduced the Pyxis PatientStation, a portable point-of-care information system that is used at the patient's bedside and is designed to reduce medication errors, improve patient safety and increase patient satisfaction. Patients can directly access the Pyxis PatientStation for information that will allow them to take a more active role in their care. Featuring secure access, the PatientStation is used by clinicians for bar code scanning to help decrease medication errors, while providing electronic medication administration record access at the bedside. Nurses, pharmacists and physicians can review patient order history, access online drug information and use bedside documentation and communication.
Radiance Medical Systems (Irvine, California) has received from the State of California Department of Health Services a sealed source and device (SS&D) registration for the company's RDX Coronary Radiation Delivery System. This registration will allow the RDX to be included in the U.S. Nuclear Regulatory Commission's SS&D Registry. The registration will permit U.S. hospitals to use the RDX in their facilities under their current license or a license amended to include the RDX for clinical trials and, upon FDA approval, for routine medical use. This registration also will make it easier for hospitals to enroll in the company's BRITE (Beta Radiation to Reduce In-Stent Restenosis) Phase II clinical trial. The BRITE II trial is a multicenter, randomized study in approximately 40 clinical centers in the U.S. The trial will determine the safety and effectiveness of the RDX System in patients who have had a coronary stent implanted and have returned to the hospital with a restenosis within the coronary artery at the site of the stent implantation. The BRITE II trial is pending FDA approval and is expected to start in the first quarter of 2001. Radiance Medical makes radiation delivery catheters used to prevent restenosis following the interventional treatment of atherosclerosis.
SpectraScience (Minneapolis, Minnesota) has received notification that the premarket approval application for its Optical Biopsy System has been approved by the FDA. The PMA approval did not mandate a post-approval clinical study. The PMA approval process did not accept the name Virtual Biopsy System, and as a result, the product will be marketed under the name Optical Biopsy System in the U.S. The Optical Biopsy System is intended for use as an adjunct during endoscopy of the colon to aid the physician in determining whether tissue in the colon is normal, pre-cancerous or cancerous, without physically removing tissue from the body. The non-invasive Optical Biopsy product operates by using light to optically scan tissue and instantly (less than 1 second) provide the physician with an analysis of the tissue. The system provides the physician with immediate results that can be used to support a decision to treat or remove suspicious tissue without the need to wait for further test results for a second endoscopic procedure. SpectraScience makes Laser Induced Fluorescence Spectrophotometry systems capable of determining whether tissue is normal, potentially cancerous or cancerous.
St. Jude Medical (St. Paul, Minnesota) has received CE-mark approval for its new Integrity Micro AutoCapture Pacing System. The company says that this is the world's smallest dual-chamber pacemaker. The new pacing system is available in both dual-chamber rate-responsive and single-chamber rate-responsive versions.
Sulzer Medica (Winterthur, Switzerland) said its Sulzer Orthopedics subsidiary has received FDA clearance for commercial release of Durasul polyethylene, a wear-resistant material, for use in its Natural-Knee implants. Knee implants typically consist of metal femoral and tibial components, with a plastic polyethylene insert sandwiched between to restore joint function. Over time, the continuous movement between the metal and plastic can cause the polyethylene to crack, pit and delaminate (flake off). It also may cause microscopic particles to break off which are in turn attacked by the body's immune system. This may lead to a condition known as osteolysis – a loss of bone tissue, which can lead to failure of the implant, requiring the patient to undergo another surgery to receive a revision implant. According to the company, Durasul directly addresses the problems of delamination and wear.
Thoratec Laboratories (Pleasanton, California) has received approval from the FDA of an investigational device exemption (IDE) supplement allowing for an additional 20 patients to be enrolled in an existing clinical trial using the company's TLC-II Portable VAD (Ventricular Assist Device) Driver. The company recently reported the submission of a premarket approval supplement seeking FDA clearance for use of the device for excursions away from the hospital and for discharge to an off-site medically monitored residence. The TLC-II is a small, lightweight device used to power Thoratec's VAD, which pumps blood to the body in heart failure patients awaiting transplant or recovery from open-heart surgery. The device has been approved for sale in Europe for more than two years. Thoratec has filed an original IDE for a new clinical trial involving home discharge of patients being supported by the TLC-II Driver while awaiting a transplant or recovery of the natural heart. Thoratec Laboratories makes medical devices for circulatory support and vascular graft applications, all of which incorporate its proprietary biomaterial, Thoralon.
TissueLink Medical (Dover, New Hampshire), a privately held medical device company, said that the FDA has given the company 510(k) clearance for the TissueLink Monopolar Floating Ball device. The Monopolar Floating Ball is a sterile, single-use device that combines radiofrequency energy with a conductive fluid for hemostasis and coagulation of tissue during surgery. It can be used in many different types of surgical procedures. TissueLink Medical makes medical devices based on its patented technology.
UltraGuide (Denver, Colorado) said that the first closed-bore magnetic resonance (MR) interventional procedure was performed using the MR Guide, the company's new real-time guidance system for minimally invasive procedures done in the MR suite. The company says that the MR Guide helps clinicians more efficiently and accurately maneuver interventional and surgical devices, using a real-time display of the needle's location and its future trajectory for both in-slice and out-of-slice approaches. The system also features a Respiratory Gating device that enables the physician to compensate for motion of the patient's anatomy during the respiratory cycle. It is designed for a variety of applications, from soft tissue and orthopedics to neuro applications. UltraGuide makes electronic guidance systems for medical applications.
Varian Medical Systems (Palo Alto, California) has introduced the Integral Mammo tube, an oil-free, compact, lightweight design for mammography equipment. According to the company, the new tube makes it possible for equipment manufacturers to offer mammography centers smaller and safer systems that are capable of serving more patients per day. The new tube uses Varian's "integral housing" design that results in higher heat dissipation rates and more efficient cooling without the need for the oil bath that is required in conventional mammography tubes. Manufacturers can also integrate the new tube into existing mammography equipment designs. The new tube weighs 6.5 pounds less than conventional tubes with comparable operating parameters, making it easier for equipment designers to balance the imaging arm assembly on their mammography systems, according to the company. Varian makes equipment for treating cancer with radiation, as well as X-ray tubes for original equipment manufacturers, replacement X-ray tubes and imaging subsystems.
Ventana Medical Systems (Tucson, Arizona) a company that supplies automated instrument-reagent systems to histology and drug-discovery labs, received premarket approval from the FDA for its CB11 antibody for Her 2/neu diagnostic testing. Ventana Medical's Pathway Her 2 (clone CB11) is a monoclonal antibody intended for laboratory use for the detection of c-erbB-2 antigen in routine pathological samples on Ventana automated immunohistochemistry (IHC) slide-staining devices. It is indicated as an aid in the assessment of breast cancer patients who could benefit from Genentech's (South San Francisco, California) Herceptin therapy. Ventana makes instrument/reagent systems that automate tissue preparation and slide staining in clinical and drug discovery laboratories.
Vital Images (Minneapolis, Minnesota), a medical visualization software company, has received FDA 510(k) clearance to market the latest release of its Vitrea 2 software product, Version 2.2. Vitrea 2 is Vital Images' imaging software for surgical planning and noninvasive diagnostic evaluation of computed tomography (CT) and magnetic resonance (MR) image data. The company says it enables physician users to create, and navigate within, 2-D and 3-D views of human anatomy. This version of Vitrea 2 features new clinical capabilities, designed specifically to aid in the diagnosis and analysis of heart disease and brain tumors. Among the software's new analytic tools is a vascular measurement function which automates the process of gathering selected vessel measurements for heart disease treatment planning. In addition, the software features significant improvements for CT colonoscopy, including enhanced integration of 2-D and 3-D visualization.
Worldwide Medical (Lake Forest, California), marketer of First Check branded home screening tests for drugs of abuse, alcohol and colorectal disease, has been granted an additional 510(k) over-the-counter clearance. The cleared tests include First Check's four primary urine-based tests for drugs of abuse: panel one for marijuana, panel two for marijuana and cocaine, panel three for marijuana, cocaine and methamphetamines, and panel four for marijuana, cocaine, methamphetamines and opiates. The category of home screening test products is emerging rapidly as a significant growth opportunity for major drug, discount and supermarket retailers. Company CEO Daniel McGuire said that the clearance "provides Worldwide Medical the opportunity to be first to market with a complete line of accurate and confidential rapid screening tests that deliver immediate drug specific results in the privacy of a home or workplace."
Xanthon (Research Triangle Park, North Carolina) said that it has been granted U.S. patent No. 6,127,127 titled "Monolayer and Electrode for Detecting a Label-Bearing Target and Method of Use Thereof." The patent describes, among other things, a proprietary method by which one member of a binding pair is attached to an electrode. This bound moiety facilitates rapid and specific detection of nucleic acids and proteins. Xanthon will use this technology in the production of its Xanthon Xpression Analysis System next year. The company says its technology will significantly improve the efficiency of the drug discovery process enabling scientists to develop safer, more effective treatments in a shorter amount of time. Xanthon is a genomics company created to commercialize an electrochemical detection technology for the direct analysis of DNA, RNA and proteins. The company's first products will be sold next year for high-throughput screening applications in pharmaceutical companies for drug discovery.