Novoste (Norcross, Georgia) in August won a recommendation for approval from the FDA's Circulatory System Devices Panel for its Beta-Cath System to treat in-stent restenosis, the first use of beta radiation for this application, which attempts to reduce the high rate of artery reclogging following angioplasty and stent placement. The approval follows the same panel's recommendation in June to approve intracoronary radiation treatment of any type for in-stent restenosis: the Checkmate Gamma Brachytherapy system from Cordis (Miami Lakes, Florida), which uses gamma radiation. In clinical trials, both systems have demonstrated about the same ability to prevent the reclosure of stented arteries. But they are clearly differentiated in terms of the types of radiation used and the details of the placement procedures.
Novoste's Beta-Cath system is a portable device that delivers beta radiation through a catheter placed inside the patient's artery following angioplasty. The system relies on strontium-90, a localized form of radiation which resides in the artery for less than five minutes and adds little time to an angioplasty procedure. Because it is localized, the procedure room requires minimum shielding and offers relatively little exposure to patient and medical staff. Thus, physicians can remain in the cath lab to monitor the procedure. Cordis's CheckMate system uses six to 10 seeds of Iridium 192, and the procedure takes from eight to 20 minutes. While the company describes the radiation effect as localized, the procedure requires greater shielding, and those performing it must leave the procedure room.
These factors create significant competitive differences between the two companies and with other types of restenosis treatments, according to Larry Haimovitch, president of Haimovitch Medical Technology Consultants (San Francisco, California), who closely follows the cardiovascular sector for Cardiovascular Device Update. Novoste's procedure "doesn't disrupt the flow of the cath lab," Haimovitch said. "Cath labs are very finely tuned organisms. They run on very tight schedules. Scheduling and a smooth flow, getting more patients in, is really important. And anything that is going to disrupt this flow, like evacuating personnel and putting big shielding in the rooms, is going to be a disruption." At the same time, the need for the assistance of radiologists during the procedure offers a marketing barrier for both companies, Haimovitch said, by creating "turf issues." Interventional cardiologists are "entrepreneurial, aggressive, independent types," he said. "Now they've got to have someone else assisting them because they aren't licensed to do it. I think that's going to be an issue."
Novoste's Beta-Cath System is commercially available in the European Union and other countries outside the U.S., but has produced only $1.2 million in sales for the second quarter, leaving it far back from the $45 million to $50 million predicted for its first year of sales. The company's premarket approval application was backed by the 476-patient START Trial, which demonstrated significant reduction in coronary blockage and the need for repeat procedures in patients treated with beta radiation vs. placebo. Cordis's application was backed by six-month angiographic results of three single- and multi-center clinical trials and showed similar ability to reduce artery reblockage.
Elsewhere in the product pipeline:
Actelion AG (Basel, Switzerland) said independent safety committees have recommended continuation, as planned, of its Phase III clinical trials of bosentan for severe chronic heart failure and tezosentan for acute heart failure, following an assessment of safety data. Recruitment for the bosentan trial, which is called Enable, is now complete. Recruitment for the tezosentan trial, which is called RITZ, is 65% complete and is expected to be finished by the end of the year, the company said. Actelion licensed the compounds, both of which are endothelin receptor antagonists, from F. Hoffmann-La Roche Ltd. (also Basel) in 1998.
Aquasearch (Kailua-Kona, Hawaii) said it initiated a randomized, double-blind clinical trial of AstaFactor for patients with coronary heart disease. AstaFactor is the company's astaxanthin-containing algal extract. The primary efficacy endpoint in the study is the reduction of C-reactive protein levels.
Avant Immunotherapeutics (Needham, Massachusetts) plans to initiate a controlled Phase IIb study of its lead complement inhibitor, TP10, in infants undergoing cardiac surgery. The study should begin before the end of the year and will be double-blind and placebo-controlled. TP10 is being studied as a potential treatment to improve post-operative outcomes in infants undergoing cardiac surgery.
Boston Scientific (Natick, Massachusetts) has received FDA clearance to market the Atlantis SR intravascular ultrasound imaging (IVUS) catheter, which the company said aids in the diagnosis of coronary artery disease. The product will be marketed by the company's cardiology division, Scimed. The product has already received the European Union CE mark and approval by the Japanese Ministry of Health and Welfare. According to the company, the catheter is the only commercially available 40 MHz IVUS catheter compatible with 6 Fr guiding catheters. The product incorporates Monorail catheter technology in its design.
CardioTech International (Woburn, Massachusetts) has developed an infection-resistant polyurethane coating based on research involving three disciplines: polymer chemistry, textile chemistry and biomedical science. According to the company, between 50,000 and 100,000 vascular catheters become infected each year in the U.S., with resulting costs estimated at more than $300 million. The research uses textile technology to incorporate broad-spectrum antibiotics into a polyurethane coating without the use of binders, resulting in long-term antimicrobial activity. The research was sponsored by a Phase I Small Business Technology Transfer grant from the National Institutes of Health (Bethesda, Maryland) and the results will be presented at a seminar, "Advances in Medical-Grade Polyurethanes," scheduled for Nov. 13-15 in Somerville, Massachusetts. CardioTech says it now has the ability to produce devices, such as vascular access grafts and indwelling catheters that are inherently infection-resistant over extended periods. The coating, based on ciprofloxacin hydrochloride may be used in both Dacron and ePTFE-based vascular grafts to help prevent infections.
Catholic University (Leuven, Belgium) released one-year follow-up data on tenecteplase, a single-bolus thrombolytic tested in the ASSENT II clinical trial, that indicates the compound has a similar efficacy to alteplase (Actilyse or Activase) in life preservation in heart attack patients. After a year, the mortality rate of tenecteplase in heart attack patients matches that of alteplase, 9.7% each. Tenecteplase is marketed in the U.S. by Genentech (South San Francisco, California) as TNKase.
Centocor (Malvern, Pennsylvania), a subsidiary of Johnson & Johnson, presented results of a Phase III clinical trial at the 22nd annual congress of the European Society of Cardiology that appear to demonstrate that a glycoprotein IIb/IIIa inhibitor may not be an appropriate treatment for certain patients with acute coronary syndrome. The findings, from the GUSTO IV-ACS trial that evaluated the safety and efficacy of ReoPro (abciximab), showed that the treatment did not show a statistically significant benefit over placebo. The drug already is on the market.
COR Therapeutics (South San Francisco, California) said the results of the PURSUIT study for the U.S. patient cohort with unstable angina was favorable for Integrilin (eptifibatide) injection. Use of Integrilin with traditional therapy of aspirin and heparin significantly reduced the occurrence of death or heart attack over 30 days, moving from 15.4% to 11.9%.
The FDA has approved the Carpentier-Edwards mitral Perimount Pericardial Bioprosthesis, a bovine pericardial tissue heart valve designed specifically for the mitral position, from Edwards Lifesciences (Irvine, California). Edwards introduced the device for U.S. aortic patients in 1991 and now adds the mitral counterpart, which the company says provides a next-generation treatment option for treating advanced mitral heart valve disease. Edwards' Perimount valve was developed by Alain Carpentier, MD, chairman of the department of cardiovascular surgery at the Hopital Europeen Georges Pompidou (Paris), working with Edwards Lifesciences bioengineers. The development involved Edwards' proprietary tissue preservation process, a wire frame stent designed using computer-aided 3-D modeling techniques, patented technology for tissue selection, and integrated manufacturing processes that make the valve able to withstand the increased pressures of the mitral position. The company says that this is the only mitral pericardial valve commercially available in the U.S. Edwards develops products and services for treatment of late-stage cardiovascular disease.
Guidant (Indianapolis, Indiana) has implanted the first patient in a clinical trial to determine the safety and efficacy of renal artery stenting in hypertensive patients. Known as Hermes (HERculink Multicenter Evaluation of Renal Stenting), the study is a prospective, non-randomized trial that will enroll about 250 patients who have experienced poor results from angioplasty to treat blockages in renal arteries. This clinical study will be conducted at 25 sites throughout the U.S. Guidant's RX Herculink 14 Peripheral Stent System is the exclusive device used in this study. The system has CE mark approval and is approved in the U.S. and Canada for the treatment of malignant biliary duct obstructions.
Medicure (Winnipeg, Manitoba, Canada) filed an investigational new drug application with Canada's Therapeutic Products Directorate for Cardoxal, an oral therapeutic in development for treatment of myocardial infarction and ischemia reperfusion injury. The company is preparing for a Phase I human clinical study in healthy volunteers. The trial will begin upon regulatory acceptance of the IND.
Meridian Medical Technologies (Columbia, Maryland) highlighted its Prime ECG electrocardiac mapping system at the annual congress of the European Society of Cardiology. European clinical studies with more than 4,000 patients found that the system detects heart attacks earlier and more accurately than traditional ECG systems, according to Meridian. The system features a wireless, disposable vest with 80 screen-printed sensors rather than the standard 12 leads used in traditional ECG systems. Advanced computer software is used to process heart signals from 64 anterior and 16 posterior points about the torso, creating full-color, multi-dimensional images designed to be more revealing and easily interpreted than a traditional ECG pattern. The School of Electrical and Mechanical Engineering at the University of Ulster (Ulster, Ireland) served as the research center for developing the new technology. The Prime ECG system has received CE mark approval and is produced at Meridian's new research and manufacturing center in Belfast.
Mogul Enterprises (San Jose, California), a privately held corporation, has received FDA clearance for its 3 Fr Steerable Decapolar Electrophysiology Diagnostic Catheter. The clearance includes a fixed curve version of this catheter. Mogul Enterprises is a startup medical company that makes devices and instrumentation related to cardiovascular applications and both minimally invasive and general surgery.
QRS Diagnostic (Plymouth, Minnesota) recently introduced its EKG Card. The company says it is the smallest and lightest electrocardiograph device available on the market. The device inserts into a computer to record and analyze up to 12 channels of high-resolution EKG data. According to the company, the device is compatible with laptop and desktop computers and offers a complete narrative interpretation package. The product has received 510(k) clearance from the FDA and will be available through the company's network of distributors and dealers worldwide beginning this month. QRS makes diagnostic and monitoring medical devices for health care providers and chronic disease management in the home.
St. Jude Medical (St Paul, Minnesota) has received an investigational device exemption from the FDA to begin its Post AV Node Ablation Evaluation (PAVE) clinical study. PAVE is a multicenter study evaluating treatment options for patients with chronic atrial fibrillation (AFib) who receive an "ablate and pace" procedure. These patients undergo an ablation procedure to reduce AFib, and implantation of a standard right ventricular pacemaker to compensate for the resulting heart block. The PAVE study will compare the effects of biventricular or left ventricular pacing with the present standard of care of right ventricular pacing. The study will collect data on more than 600 patients in up to 65 centers worldwide. During the trial, patients will be randomized to right ventricular, left ventricular or biventricular pacing for six months. Patients who are randomized to left ventricular-based pacing also will receive a right ventricular lead to provide backup right ventricular pacing. St. Jude's Genesis system will be implanted in patients who are randomized in the PAVE study to left ventricular-based pacing. The Genesis system is a device-based ventricular resynchronization system for the treatment of heart failure available in Europe.
Vitatron (Dieren, the Netherlands), a subsidiary of Medtronic (Minneapolis, Minnesota), has released for commercialization its Vitatron Selection AFm (Model 902) pacing system. According to the company, the new system continuously monitors the patient's rhythm 24 hours a day and stores relevant atrial arrhythmia information that enables physicians to target atrial fibrillation onset, including the number and length of episodes. The device has dual-chamber pacing features, beat-to-beat mode switching and dual sensor physiologic rate response pacing therapies that the company says help reduce arrhythmia symptoms. The company says that the monitoring capabilities in the system offer physicians the ability to identify underlying rhythms, target the onset mechanism, monitor the action of the ventricles (lower chambers) during atrial (upper chamber) fibrillation episodes and analyze the effect of drugs or other therapies.