Biosite (San Diego, California) presented results of the BNP (Breathing Not Properly) Multinational Study: B-type Natriuretic Peptide (BNP) in the Emergency Diagnosis of Heart Failure during last month's American College of Cardiology annual scientific session in Atlanta, Georgia. The trial, which used the Triage BNP Test, included 1,586 patients and examined whether measuring BNP immediately upon patient presentation to the emergency department would be helpful in distinguishing between cardiac and non-cardiac causes of acute shortness of breath. Peter McCullough, MD, chief of cardiology at the University of Missouri-Kansas City School of Medicine (Kansas City, Missouri), said that in the study, "BNP was the single most accurate predictor of congestive heart failure (CHF)."
Biosite secured a semi-exclusive license to BNP from Scios (Sunnyvale, California) in 1997. The Triage BNP Test is the first blood test to receive FDA clearance as an aid in the diagnosis of congestive heart failure. In 15 minutes, the test measures circulating levels of BNP, which are elevated during heart dysfunction in both symptomatic (late-stage) and asymptomatic (early-stage) CHF patients.
Elsewhere in the product pipeline:
Artemis Medical (Hayward, California) released the MammoMark Biopsy Site Identifier, designed to facilitate more accurate and precise post-procedure identification of the biopsy site. It incorporates self-expanding collagen with a centrally located titanium clip. Placed in the biopsy site, the MammoMark hydrates and conforms to the size and shape of the biopsy cavity. It is echogenic and radiopaque, helping physicians identify the biopsy site using ultrasound or mammography. It resorbs within a matter of weeks, leaving the titanium clip for long-term follow-up.
AtCor Medical (Sydney, Australia) received FDA approval to market its SphygmoCor Px Aortic BP profile system, a cardiovascular evaluation tool. It noninvasively measures the blood pressure profile in the ascending aortic artery. The physicians' office device, which assesses arterial stiffness and its impact on cardiac function, already was approved in Europe and Japan. It allows physicians to track changes in arterial stiffness, left ventricular load, coronary artery perfusion pressures, cardiac timing and cardiac reserve.
Bacchus Vascular (Santa Clara, California) was granted 510(k) clearance from the FDA to market its Trellis Infusion Catheter, a percutaneous system designed to facilitate the delivery of physician specified agents, including thrombolytics, into the peripheral vasculature. The device also has received CE mark certification. Trellis technology is based on a vibratory pharmacomechanical platform that permits efficient, localized mixing of infused fluids. The Trellis System is used in conjunction with routinely used interventional procedures, done over a guidewire and through an introducer sheath.
Beckman Coulter (Fullerton, California) released a high-sensitivity laboratory test called CRPH to help physicians determine a patient's risk of coronary artery disease. CRPH measures levels of C-reactive protein (CRP), a protein produced in the liver and released into the bloodstream as a result of infection or injury, such as tissue damage or inflammation caused by coronary artery disease. The test can be performed as part of a routine physical exam. The company said high-sensitivity CRP testing in conjunction with other screening methods, such as tests that measure cholesterol, body weight and blood pressure, can improve diagnosing risk of cardiovascular disease. It also can aid in the evaluation of stress, trauma, infection, inflammation, surgery and associated diseases.
Biolase Technology (San Clemente, California) received the first FDA clearance for laser cutting, shaving, contouring and resection of oral osseous tissues. The Waterlase product allows patients to undergo significant surgical procedures with fewer complications and little or no post-operative pain, and bone procedures can be done much less invasively, resulting in faster healing.
BSD Medical (Salt Lake City, Utah) integrated a Siemens MRI system with its deep phased-array microwave hyperthermia system, the BSD-2000/3D, at the same time reporting that it has acquired the rights under a patent license from the National Institutes of Health to bring this technology to the U.S. The coupling of these technologies was pursued and patented by the NIH because noninvasive treatment monitoring is considered a goal of deep hyperthermia cancer therapy. It provides simultaneous imaging (including temperature monitoring) of deep tumors. Working with Siemens Medical Systems (Iselin, New Jersey), BSD integrated a specially adapted BSD-2000/3D with the 1.5 Tesla Siemens Magnetom Symphony MR in an installation at Charite Medical School of Humboldt University (Berlin, Germany).
Collateral Therapeutics (San Diego, California) said the American Heart Association (Dallas, Texas) issued a press release featuring results from the Phase I/II trial for Generx, which appeared in an issue of Circulation. The AHA said that "transferring growth factor genes into the heart appears safe and shows promise for treating the debilitating chest pain known as angina." Generx (Ad5-FGF4), a non-surgical angiogenic gene therapy, is being evaluated as a potential treatment for patients with stable exertional angina due to coronary artery disease.
Confluent Surgical (Waltham, Massachusetts) reported positive results of its pilot clinical trial of its lead product, SprayGel Adhesion Barrier, at the World Congress on Endometriosis in San Diego, California. SprayGel is designed to reduce or eliminate adhesions after gynecological surgery. The study, conducted at two U.S. clinical sites with 14 randomized patients, showed that the incidence of adhesion formation to the SprayGel treated adnexa was found to be 71% reduced at the time of second-look surgery. The extent of adhesion formation was reduced by 69%. SprayGel forms a flexible adhesion barrier that is tightly adherent to tissue, remains intact for about a week, and is then absorbed, allowing surgically injured tissues to heal without forming a scar or adhesion with surrounding organs. SprayGel is CE marked, but not approved for U.S. sales.
CryoCath Technologies (Montreal, Quebec) received CE mark approval for its Freezor Xtra, which produces deeper, wider and longer lesions than the original Freezor product. Freezor Xtra is a line extension of the original model, designed to deliver maximum cooling power to a larger tip, which facilitates the creation of larger lesions. Both catheters work on the existing CryoConsole. The original Freezor was specifically designed to create focal lesions and to treat arrhythmias near the AV node where precision is of critical importance. The Freezor Xtra is designed to treat arrhythmias further from the AV node that require more robust lesions, such as AF, AFL, and VT. The Xtra version can create lesions that are significantly larger than those of the original, potentially reducing procedural time. The company is targeting U.S. approval in 2004.
Digene (Gaithersburg, Maryland) received clearance to market its Hybrid Capture 2 HPV Test in Japan for the detection of human papillomavirus (HPV) as a follow up to borderline Pap smear test results. The HC2 HPV Test is the only FDA-approved test for HPV, which studies have shown is the primary causal factor in the development of cervical cancer. Mitsubishi Kagaku Medical (Tokyo) will distribute the test in Japan. In addition, Digene recently filed with the FDA to use its HC2 HPV DNA Test in conjunction with the Pap smear as a primary screen for cervical cancer and its precursors in women age 30 and over. In February, Digene and Cytyc (Boxborough, Massachusetts) signed a definitive merger agreement in which Cytyc will acquire Digene in a stock-and-cash transaction.
Diomed (Andover, Massachusetts) released the first FDA-cleared, combined laser system that treats vascular lesions, including spider veins and varicose veins. Diomed reported earlier this year that it had gained FDA clearance to market EVLT (EndoVenous Laser Treatment), a minimally-invasive, laser-based varicose vein treatment that eliminates varicose veins without hospitalization, general anesthesia or open surgical procedures. With the new clearance for the D15plus and D30plus laser systems and handpieces, Diomed said it is the first company to offer one laser system that can be used for multiple vascular applications — EVLT and the treatment of spider veins.
Edwards Lifesciences (Irvine, California) said one of its catheters was used during an aggressive intervention method called Early Goal-Directed Therapy (EGDT), part of a study of 263 patients treated for severe sepsis or septic shock in emergency rooms. Patients treated with a catheter that measured their central venous oxygen saturation (ScvO2) as part of an early, aggressive regimen had better overall outcomes, including lower mortality rates and shorter hospital stays, than patients receiving standard care, according to research presented at the Symposium on Critical Care, Trauma and Emergency Medicine in Las Vegas. The study showed that patients receiving EGDT had a lower in-hospital mortality rate — 30.5% compared to 46.5% among those receiving standard care; lower incidences of organ failure; and shorter hospital stays — 14.6 days compared to 18.4 days for those receiving standard care. The Edwards catheter used in the study is now available in limited commercial release in the U.S., and the company also is exploring its potential application in Europe.
Emergency Filtration Products (EFP; Las Vegas, Nevada) received FDA approval as a Class II medical device for its 2H Technology Breathing Circuit Filter (2H Filter), which captures and isolates infectious pathogens by removing moisture and particulate from airflow at high levels of efficiency. The 2H Filter combines hydrophilic (moisture absorbent) and hydrophobic (moisture repellent) filter media. The filter, compatible with numerous applications in ventilators, respirators and anesthesia circuits, is EFP's first device in a planned series of circuit filters targeting the worldwide hospital market.
Endocare (Irvine, California), a developer of diagnostic and treatment tools for cancer and other diseases, submitted its second premarket approval module to the FDA for its Horizon Prostatic Stent, a device designed to relieve suffering from acute urinary tract blockage. The Horizon stent, made of nitinol, features a shape-memory feature that allows it to be introduced and removed from a man's body through a minimally invasive procedure. Endocare said it was broadening its urology franchise and extending its national sales force with the acquisition of Timm Medical Technologies, a privately held medical device manufacturer and distributor.
E-Z-EM (Westbury, New York) received 510(k) clearance to market its Protoco2L colon insufflation system, consisting of an automated insufflation device and disposable administration sets, for virtual colonoscopy procedures. The product uses carbon dioxide to distend the colon for accurate imaging diagnosis and patient comfort. The company said the Protoco2L colon insufflation system makes carbon dioxide insufflation a practical and simple procedure for the practitioner. E-Z-EM said gas pressure is regulated and constant, minimizing the pressure spikes that can occur during manual insufflation.
Guidant (Indianapolis, Indiana) reported CE mark approval of the Easytrak 2 lead, its next-generation heart failure therapy lead using its transvenous over-the-wire design. Easytrak 2 builds on the original Easytrak lead, adding a dual-electrode design for multiple programming options including bipolar pacing and sensing. Its dual-electrode design provides increased flexibility in using the programmable pacing and sensing options available in the Contak Renewal device. The Easytrak 2 lead design allows physicians to position the pacing electrodes in a vein on the left side of the heart using an over-the-wire technique similar to the system used in angioplasty procedures. Easytrak 2, in conjunction with leads implanted in the right side of the heart, allows a device from Guidant's Contak Renewal family of heart failure pulse generators to independently sense and stimulate the left and right sides of the heart.
ICN Pharmaceuticals (Costs Mesa, California) said its subsidiary, ICN Photonics, received FDA clearance to market the Nlite System, a non-ablative laser system for use in dermatological and plastic surgery treatment of general wrinkles. Previously, the product was cleared to treat periocular (around the eyes) wrinkles only. Additional marketing authorization was granted to increase the diameter of laser-to-body surface contact from 5 mm to 7 mm. ICN said the Nlite laser safely removes wrinkles without damaging the skin's surface. The technology uses highly specific laser light to target microvasculature in the papillary dermis, stimulating the body's own collagen layer to replenish itself. The 20-minute procedure requires no anesthesia and no post-operative care.
I-Flow (Lake Forest, California) was awarded a U.S. patent for its catheter infusion technology for post-operative pain relief of large surgical incisions. The device, part of I-Flow's ON-Q Pain Management System, delivers anesthetics over a wide area, providing better pain control of surgical procedures requiring large incisions without the undesirable side effects of narcotic pain relievers.
Life Medical Sciences (Oceanport, New Jersey) began the feasibility clinical trial on its Repel-CV bioresorbable adhesion barrier, designed to reduce the formation of scar tissue on the surface of the heart after open-heart surgery. The trial will assess the efficacy of Repel-CV in preventing and reducing adhesion formation in neonatal patients who require a staged series of open-heart surgical procedures as well as provide additional data on its safety profile.
LumiCyte (Fremont, California) said it is moving forward with clinical trials to evaluate its newly discovered protein biomarker profiles for the early detection of various cancers. These biomarkers were discovered using LumiCyte's rights to the proprietary SELDI (Surface-Enhanced Laser Desorption/ Ionization) technology. The company expects its SELDI-based protein biomarker discovery and validation services will result in the development of products to improve diagnosis and patient care.
Medinex Systems (Orlando, Florida) released MxMail, a HIPAA-secure electronic messaging system designed for hospitals. The system enables hospitals to provide secure, e-mail style electronic messaging services to physicians, labs and patients in their community. The MxMail system has been integrated with Medinex Office, the company's suite of medical technology services.
Medtronic (Minneapolis, Minnesota) released the 2.75 mm S660 Coronary Stent System with Discrete Technology, which recently received premarket approval from the FDA as well as CE mark approval in Europe. The system is available for use in small-vessel stenting procedures. The S660 stent system, first introduced to the market in April 2000 in a 2.5-mm size, is designed for use in vessels that are 2.2 mm to 2.9 mm in diameter. It is indicated for use in abrupt or threatened closure of vessels and is designed for post-percutaneous transluminal coronary angioplasty deployment. Of that figure, about 20% involve the treatment of small vessels (less than 3.0 mm). The 2.75 mm S660 stent system incorporates six-crown architecture, a metal-to-artery ratio and strut thickness optimized for use in small vessels.
Mercury Computer Systems (Chelmsford, Massachusetts) released extensions to its RACE++ family of high-performance embedded computer systems. The extensions achieve speeds of up to 20 times faster than previously possible for processing high-resolution, 3-D medical diagnostic images. Mercury said its sub-system design will improve the speed and accuracy of diagnosis and treatment in time-critical situations. The extensions provide more processing capability in a smaller form factor.
Merge Technologies (Milwaukee, Wisconsin) released MergeNet, a product within its PACSbuilder suite of radiology workflow solutions. The browser-based application combines radiology reports with associated images and delivers them over the web using Merge's ImageChannel wavelet streaming technology. Software maintenance and upgrades are easily managed through web-based software downloads that limit the amount of service and support necessary on each end-user PC.
Merit Medical Systems (South Jordan, Utah), which manufactures disposable products used in cardiology and radiology procedures, introduced the One-Step centesis catheter and the Inject8 Palm Pad syringe. Centesis catheters are used in a number of procedures to drain fluid from cavities within the body such as the abdomen, chest and lungs. One-Step is one of three catheters planned for release this year. The Inject8 Palm Pad is an additional model in the company's line of Inject8 coronary control syringes. Inject8 requires up to 40% less injection force because of its smaller barrel size, making it ideal for injecting contrast media by hand through smaller catheters.
MicroVention (Alison Viejo, California) received 510(k) clearance from the FDA, as well as CE mark approval, to market its MicroPlex Coil System for the treatment of cerebral aneurysms. The product consists of both helical coils and a unique complex coil. The coils are detached from a catheter by the physician using a HydroLink detachment system that uses micro-fluidic actuation for instantaneous release. The company plans to sell the product through its own direct sales force in the U.S., France and Germany, and through distributors elsewhere.
Molecular Diagnostics (Chicago, Illinois) began shipping its InPath In-Cell HPV probe for the detection of E6 & E7 oncogenes. Clinical trials for the In-Cell HPV assay are beginning as an extension of Molecular Diagnostics' current clinical trials for the InPath Cocktail-CVX, another biomolecular assay intended to detect cervical lesions, in much the same way as the Pap test does now.
Neoprobe (Dublin, Ohio) said its Biosonix subsidiary received notification from the FDA that its FlowGuard diagnostic product has been cleared for U.S. marketing. FlowGuard has been cleared for use in the determination of blood flow in noninvasive diagnostic and intraoperative applications. FlowGuard received CE mark clearance late last year. It uses the Angle-independent Doppler Blood Flow (ADBF) technology developed by Biosonix that the company said is substantially less invasive and more specific than alternative methods. Separately, Neoprobe reported that Biosonix has received approval from the appropriate authorities in Israel to change its corporate name to Cardiosonix Ltd.
Palomar Medical Technologies (Burlington, Massachusetts) unveiled LUX R, a handpiece for the its EsteLux light-based system, at the American Academy of Dermatology meeting in New Orleans, Louisiana. The red-light filtered hand piece is used for hair removal on all skin types, including tanned skin, along with its other recently introduced EsteLux system hand pieces. The LUX Y yellow-light filtered hand piece works on lighter skin types, and the LUX G green-light filtered hand piece is used for vascular lesion treatments. The product also is being evaluated for hair reduction and for the treatment of Pseudofolliculitis barbae, a common skin disorder that occurs primarily in African Americans, with more than 50% incidence within this population, and other persons with thick, curly hair. The company also received FDA clearance for its SLP1000 Diode Laser System in the treatment of Pseudofolliculitis barbae. The system has already been cleared for permanent hair reduction and treatment of vascular lesions.
Phase Forward (Waltham, Massachusetts) launched its RegTracker product data management system, which enables pharmaceutical companies to manage information for regulatory and marketing authorization purposes. As a data repository, the RegTracker database stores all relevant information about products from a regulatory perspective.
PhotoMedex (Radnor, Pennsylvania) said its proposal for a CPT code for reimbursement of the Xtrac laser therapy was approved. New codes will become effective Jan. 1 and will facilitate tracking and billing for these services. The Xtrac laser can deliver focused 308nm wavelength at a higher power than non-laser or lamp alternatives thereby allowing for fewer patient treatments, delivered in less treatment time, without exposing the skin to UVB spanning broader wavelengths. The company's excimer laser system generating 308-nm UV-B radiation is the first FDA-approved laser treatment for psoriasis, the second-most-common skin disorder in the U.S. Xtrac is also the first FDA-approved excimer laser system to treat vitiligo and eczema.
Physiometrix (North Billerica, Massachusetts) submitted to the FDA its 510(k) application for its PSArray2, a frontal-only disposable array used with the company's PSA 4000 consciousness-monitoring system, which received 510(k) clearance in 2000.
Polymedco (Cortlandt Manor, New York) is offering a variety of lipid assays including apolipoprotein A-I, apolipoprotein A-II, apolipoprotein B, apolipoprotein C-II, apolipoprotein C-III, apolipoprotein E, NEFA, Lp(a), and remnant lipoprotein cholesterol. The company said the lipids play an integral role in the diagnosis and monitoring of coronary artery disease and the assessment of coronary risk. These new emerging markers are expected to play a major role in prediction and assessment of heart disease, especially in patients demonstrating normal conventional lipid levels.
Quest Diagnostics (Teterboro, New Jersey) released an updated version of its ultra-sensitive Heptimax hepatitis C viral load test using Roche Diagnostics' (Mannheim, Germany) Cobas TaqMan platform. Heptimax allows physicians to order one test for all hepatitis C viral load testing needs. Its sensitivity ranges from five IU/ml to greater than 50 million IU/ml. Quest acquired the real-time PCR technology under its alliance with Roche to develop and commercialize new gene-based medical tests using Roche's polymerase chain reaction (PCR) technology. The TaqMan testing platform enables Quest to provide one-day turnaround for the vast majority of infected patients by using real-time PCR, compared to up to three days using previous methods.
RITA Medical Systems (Mountain View, California) said results of a study on the use of its radiofrequency ablation technology show the minimally invasive treatment appears to be effective in treating cancerous lung tumors when surgery is not an option. Data were presented at the European Congress of Radiology. The clinical study included 34 patients who had primary lung cancer or lung metastases (cancer which has spread to the lung) and who were not surgical candidates. For 26 patients who had been followed for at least three months (mean follow-up of 8.6 months), complete tumor response was observed in 95% of the treated tumors. There were no major complications reported.
SonoSite (Bothell, Washington) reported results of a study examining the effectiveness of the SonoSite 180 system in detecting blockages in carotid (neck) arteries during the American Stroke Association's International Stroke Conference in San Antonio, Texas. The study, conducted at Wake Forest University (Winston-Salem, North Carolina), screened carotid arteries using the SonoSite 180 system in a prospective study of 51 patients. The SonoSite 180 system can be carried by the examiner to the screening site in a backpack, rather than requiring the patient to go to an imaging center or radiology department.
St. Jude Medical (St. Paul, Minnesota) said it received FDA approval for the SJM Regent heart valve, the company's newest mechanical heart valve. St. Jude said the SJM Regent valve offers "exceptional structural integrity, durability and low complication rates." It features what St. Jude called "subtle design modifications" to its pyrolytic carbon components. The heart valve has been marketed in Europe and Canada since 1999, and it now makes up a significant percentage of the company's aortic valve sales mix in the international markets where it is available.
Summit IT (Eden Prairie, Minnesota) has launched HIPAAnswers, a software tool to assist health care organizations in understanding HIPAA regulations, and to assess, track and do compliance activity. The web-enabled application, available through a secure website, was created to keep costs down for small- to mid-sized group physician practices, hospitals, skilled nursing facilities, chiropractors, vision providers and other organizations.
TeraRecon (San Mateo, California) reported advances in its AquariusNET PACS system at the European Congress of Radiology. It said AquariusNET is a solution to the challenges faced by facilities that need to manage increasing numbers of images generated by multi-detector CT and magnetic resonance scanners. The system also supports archiving and reviews of images from CR/DR and X-ray angiography. Fully integrated 2-D and 3-D review are provided for, with simultaneous side-by-side review of several studies possible in 2-D, 3-D or 4-D, even from different modalities. From one client station, a radiologist may prepare a report and file it on the server, so that it becomes available to any other client on the network and may be e-mailed to a referring physician or other recipient.
Symphonix Devices (San Jose, California) said its pivotal paper, "Phase III Clinical Trial Results with the Vibrant Soundbridge Implantable Middle Ear Hearing Device — a Prospective Controlled Multi-Center Study," was published in the February issue of Otolaryngology Head and Neck Surgery Journal. Results of the study supported FDA approval as treatment for those with moderate-to-severe sensorineural hearing loss. The trial was conducted at 10 U.S. centers on 53 subjects, each an experienced hearing aid user who was actively seeking a superior alternative to traditional acoustic hearing aids. Results demonstrated a significant increase in patient satisfaction with the Vibrant Soundbridge in challenging listening environments.
Urologix (Minneapolis, Minnesota) began U.S. clinical trials under an investigational device exemption for its Cooled ThermoCath treatment catheter. The first patients treated under the IDE were enrolled in a trial at the Virginia Urology Center (Richmond, Virginia). Trials will be conducted at four additional U.S. sites. Preliminary findings indicate Cooled ThermoCath provides greater comfort and increased tissue necrosis. Its technology uses targeted microwave energy, combined with a unique cooling balloon that conforms to the prostatic urethra, enhancing urethral cooling and allowing for deeper heat penetration into the prostate. Positive results also were reported from three international sites.
W. L. Gore & Associates (Flagstaff, Arizona) received 510(k) clearance from the FDA to market the Viabahn Endoprosthesis, indicated to treat tracheobronchial strictures produced by malignant neoplasms or in benign strictures after alternative therapies have been exhausted. The product is a flexible, self-expanding, implantable endoprosthesis that is compressed and secured on the distal end of a catheter delivery system. The endoprosthesis component is constructed from an expanded polytetrafluoroethylene tubular lining with a helical nitinol reinforcement stent. It is available in 6 mm to 13 mm diameters. The delivery catheter is available in 75 cm and 110 cm working lengths, has radiopaque markers to aid in placement and is compatible with up to 0.025" diameter guidewires.