The FDA last month approved for marketing two devices that use radiation for the treatment of clogged arteries following balloon angioplasty. With those decisions, two device companies – Cordis (Miami Lakes, Florida) and Novoste (Norcross, Georgia) – reached the clearance finish line at the same time, although Cordis had received an earlier recommendation of approval from an FDA advisory panel.

Now the two firms will begin the race to achieve leadership in this sector, a specialized treatment that attempts to avoid the recollapse of arteries following balloon angioplasty and the placement of stents – a problem that has been the primary drawback to this otherwise very beneficial technology.

Novoste's technology is termed the Beta-Cath System. The Beta-Cath is used by reopening the artery and hydraulically placing Strontium-90 beta radiation seeds to the treatment site at the end of the closed-end catheter. The seeds remain there for three to five minutes and are then withdrawn. In trials, the system reduced the rate of restenosis by 36% to 66% as compared to placebo.

The system from Cordis, a unit of Johnson & Johnson (New Brunswick, New Jersey), is dubbed the Checkmate Gamma Brachtherapy System. It too provides intravascular radiation. As with the Beta-Cath System, a catheter is used to reopen the artery, preliminary to placing a dose of six to 10 seeds of Iridium 192, a low-dose radiation that prevents the formation of clog-forming cells.

While the general technology for the two systems is the same, they have some key differences. While the Beta-Cath system requires only a few minutes to complete, the Checkmate system requires up to an hour for completion. Additionally, the Beta-Cath system does not require a high degree of shielding, and staff does not have to leave the procedure room during the procedure. With the Checkmate system, the use of gamma radiation requires the doctors to leave the procedure area to avoid exposure.

These factors offer key competitive distinctions between the two, according to Larry Haimovitch, president of Haimovitch Medical Technology Consultants (San Francisco, California), who follows the cardiovascular sector for The BBI Newsletter and its sister publications, Cardiovascular Device Update and Medical Device Week. Because Novoste's procedure doesn't require staff to leave the procedure area, it is "less likely to disrupt the flow of the cath lab," he told BBI. "Cath labs are very finely tuned organisms ... scheduling and a smooth flow, getting more patients in, is really important. And anything that's going to disrupt this flow, like evacuating personnel and putting big shielding in the rooms, is going to be a disruption."

Both systems may be facing some tough brands of oncoming competition in the future, however, with the development of new drug treatments for in-stent restenosis and, ultimately, genetic therapies.

Cordis received unanimous approval of the Checkmate System in June based on clinical trials that, like Novoste's product, showed a significant reduction in rates of restenosis. The approval was given, however, with conditions. At the time, the company was required to provide more informative labeling, especially for risks to pregnant women and prior radiation patients. The panel also asked Cordis to provide information concerning the use of a specialized team to carry out the treatment.

Jesse Penn, president of Cordis, said the Checkmate System "offers the unprecedented opportunity to make the winning move in this ongoing battle against in-stent restenosis." He estimated 100,000 patients in the U.S. currently needing treatment for in-stent restenosis, and he specifically noted Checkmate's ability to treat long lesions and lesions in small vessels. "Small vessels and long lesions are especially common among diabetics. The Checkmate System has produced some outstanding efficacy results in a variety of patients, including diabetics," Penn said.

One of the lead investigators in Novoste's clinical trials was David Cox, MD, of Presbyterian Hospital (Charlotte, North Carolina). In a statement, Cox said that no previous treatments for in-stent restenosis "have produced results that come even close to the profound results demonstrated with vascular brachytherapy in multiple randomized trails."

Elsewhere in the product pipeline:

Acusphere (Boston, Massachusetts) has been issued U.S. patents 6,132,199 and 6,045,777 related to the company's intravenous delivery system for gas, which is being developed as an ultrasound contrast agent for the detection of coronary artery disease. One patent covers synthetic polymer compositions used to deliver any fluorinated gas, which the company believes is the best class of gases for ultrasound imaging. Acusphere is believed to be the only company with technology for delivering fluorinated gas with synthetic polymers. It has used synthetic polymers to overcome the limitations of earlier-generation ultrasound contrast agents made from natural materials such as albumin, sugars and lipids. The other patent describes technology for how synthetic polymers can be used to engineer important product characteristics. The patent defines the optimum shell thickness for minimizing shadowing and maximizing ultrasound reflection, and covers any gas-filled microparticle for ultrasound contrast imaging with a shell thickness in that optimum range. With less shadowing, said the company, the AI-700 ultrasound contrast agent can provide clearer ultrasound images with the potential to improve sensitivity and specificity.

Biomatrix (Ridgefield, New Jersey) said a study presented at the 64th annual meeting of the American College of Rheumatology (Thorofare, New Jersey) showed that hip osteoarthritis patients treated with intra-articular Synvisc (hylan G-F20) exhibited significant and sustained symptomatic relief. The data provided the first evidence that Synvisc, approved in the U.S. as a viscosupplement and as a knee osteoarthritis therapeutic in 50 other countries, may be safe and effective in reducing pain and improving functionality for hip osteoarthritis patients.

Calypte Biomedical (Alameda, California) said it is collaborating with the Osborn Scientific Group to develop two urine-based rapid HIV antibody tests. Once the assays are completed and have received regulatory clearance, Calypte and Osborn expect the products to be the first urine-based rapid HIV antibody tests. The tests will be similar in function to home pregnancy tests, which also use urine as the sample fluid. Initial evaluations of Osborn's assay technologies are encouraging, and the two companies are working to finalize development of the tests during the coming year. Calypte and Osborn expect that their urine-based rapid HIV tests will provide safe, cost-effective, painless results within 15 minutes without lengthy laboratory analysis.

Cochlear (Denver, Colorado) received FDA approval for its Nucleus 24 Contour cochlear implant system. The company said that this system broadens the eligibility criteria for cochlear implant candidates to include infants as young as 12 months and individuals with more residual hearing. The company feels that the Nucleus 24 Contour's self-curling electrode array matches the curvature of the average cochlea, allowing closer proximity of electrodes to the hearing nerve fibers. The device has the ability to stimulate 22 sites along the cochlea, allowing a broad pitch range of sound, which can enhance speech recognition. Cochlear is a cochlear implant technology company.

Critikon (Tampa, Florida) received FDA market clearance for the Dinamap Pro 1000 featuring electrocardiogram (ECG) capabilities. Designed specifically for the growing sub-acute care market, the system combines ECG with three other technologies. In addition to 3-lead ECG capabilities, the monitor uses Nellcor pulse oximetry by Mallinckrodt (St. Louis, Missouri), IVAC predictive thermometry by Alaris Medical Systems (San Diego, California) and Dinamap ASAP by Critikon. The company said that this NIBP technology automatically adjusts for lower inflation pressures on blood pressure readings. Critikon makes noninvasive patient monitoring systems.

Endocare (Irvine, California), a provider of temperature-based technologies designed to treat cancer and benign prostate growth, said that cryosurgery was issued a permanent CPT code for reimbursement in the 2001 edition of the Medicare Physician Fee Schedule published by the Health Care Financing Administration (HCFA; Baltimore, Maryland). This class of procedure, which includes the Endocare Targeted Cryoablation Procedure (TCAP), had been assigned temporary reimbursement codes with the national Medicare coverage decision that became effective in July 1999. In order for a procedure to be assigned a permanent CPT code, a certain number of the procedures must be performed and a certain number of physicians must be trained to perform the procedure. TCAP is the use of cryoablation (application of extreme cold to destroy tissue) in combination with ultrasound and temperature monitoring to precisely destroy cancer cells.

Gambro AB (Stockholm, Sweden), an international medical technology and health care company, has received FDA approval for a synthetic dialyzer for reuse applications. Initially, the dialyzer is primarily intended for Gambro's own clinics within Gambro Healthcare. It will replace external sourcing of reusable dialyzers and is part of Gambro's expansion strategy in the field of dialyzers. The annual volume potential is more than 1 million dialyzers, according to the company. The dialyzer is Gambro's synthetic Polyflux filter, marketed for hemodialysis and convective treatments where the selection of membrane structure and polymer materials are of high importance.

Guidant (Indianapolis, Indiana) has enrolled the first patients in a clinical trial to determine the safety and feasibility of stenting in patients with cerebrovascular disease. Guidant's SSYLVIA (Stenting in SYmptomatic atherosclerotic Lesions of Vertebral and Intracranial Arteries) trial is a non-randomized, prospective study that will enroll approximately 30 patients with cerebral atherosclerosis. The study will be conducted at five centers in the U.S. and eight centers in other countries. The trial will use Guidant's Neurolink System, which is designed to treat atherosclerosis of the intracranial arteries and extracranial vertebral arteries. The investigational system is comprised of a balloon dilatation catheter for pre- and post-dilatation and the Neurolink stent, which is pre-mounted on a delivery catheter. Once deployed, the stent serves as scaffolding to hold previously blocked arteries open, improving blood flow through the cerebral artery and potentially reducing the risk of future ischemic stroke, according to the company.

Hitachi Medical Systems America (HMSA; Twinsburg, Ohio) has received FDA 510(k) clearance to market its new Altaire high-field performance open magnetic resonance imaging (MRI) system. Shipments of the Altaire system will begin in 1Q01. According to the company, Altaire combines the advantages of high-field performance and open MRI. HMSA markets Hitachi Medical's (Tokyo) MRI products.

Hypertension Diagnostics (HDI; St. Paul, Minnesota) has received FDA clearance to market the CVProfilor DO-2020 CardioVascular Profiling System for use by physicians and other health care providers to non-invasively screen patients for the presence of cardiovascular disease. In addition to measuring blood pressure values (systolic, diastolic and mean arterial pressure) and heart rate, the system calculates pulse pressure, body surface area and body mass index, and provides indications of arterial elasticity. The company said that the system determines both large and small artery elasticity indices that can be used as an initial clinical screening device to determine if patients have potential underlying vascular disease.

Med-Design (Ventura, California), a maker of safety needle products for medical use, received a U.S. patent covering its proprietary centerline retraction technology in prefilled needle injection devices. The company's safety needle products cover applications in blood collection, infusion therapy, insertion and injection.

Meridian Medical Technologies (Columbia, Maryland) has received FDA marketing clearance for the CardioBeeper CB12/12 cardiac monitor, a device that allows heart patients to transmit a complete 12-lead electrocardiogram (ECG) from home or office over a standard telephone line. The CB12/12 is expected to replace the CB12L currently marketed through Meridian's marketing partner to Israel and portions of Europe. Recently introduced in Israel, the system is manufactured by Meridian and marketed by Shahal Medical Services (Tel Aviv, Israel). With the FDA approval, Shahal intends to market the device in the U.S. Designed for monitoring patients who have cardiac-related symptoms such as chest pain or irregular heartbeats, the monitor transmits data that is interpreted by medical personnel who can provide diagnosis, advice and treatment when appropriate.

Micro Therapeutics (MTI; Irvine, California) received CE-mark approval for its Onyx Liquid Embolic System for the treatment of brain aneurysms. Onyx, a liquid embolic material, is delivered through MTI's micro catheters directly into an aneurysm. Once inside, Onyx transforms into a spongy polymer mass intended to seal off the aneurysm, thus reducing the risk of rupture and subsequent stroke. In July, MTI initiated its CAMEO (Cerebral Aneurysm Multi-Center European Onyx) Study. By the end of this year, MTI expects to have eight European sites involved in this study, which will serve to provide data as part of MTI's commercialization plan. FDA approval was received in August. Commercial orders for Europe are expected to commence in early 2001 and will be handled by Guidant, MTI's exclusive distribution partner in Europe.

Nymox Pharmaceutical (Maywood, New Jersey) said that recent studies have demonstrated that the Nymox-Serex nicotine dipstick test is a highly useful adjunct to smoking cessation regimes and for measurement of secondhand smoke exposure. The test is designed for monitoring the exposure of pregnant women to smoke, for monitoring smoking cessation efforts in smokers, and for assessments of cardiac and pulmonary patients. The company said the test is the only quantitative point-of-care nicotine test available in the world.

STAAR Surgical (Monrovia, California) said that the FDA's Ophthalmic Device Panel recommended approval of the company's pending premarket approval application for the STAAR AquaFlow Collagen Glaucoma Drainage Device. The panel recommended approval with the understanding that STAAR would continue the two-year study after approval and make minor modifications to the device's labeling.

St. Jude Medical (St. Paul, Minnesota) released a new electrophysiology catheter to assist clinicians in the diagnosis and treatment of supraventricular tachycardias. The Livewire Duo-Decapolar catheter, with special electrode spacing, allows physicians to simultaneously map in both the right atrium and coronary sinus with a single steerable catheter. According to the company, this new model in the Livewire product line can reduce the number of catheters used during an electrophysiology procedure as well as the number of vascular access sites in the patient. The Livewire product line includes mapping and ablation catheters for the treatment of various arrhythmias.

Synthetic Blood International (SBI; Kettering, Ohio) has been granted an Australian patent covering the company's glucose biosensor system. In particular, it protects the biosensor and membrane-enzyme complex that regulates the availability of glucose that permits accurate measurement of glucose levels with low ambient oxygen tension.

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