Cardima (Fremont, California) reported preliminary data from its Revelation Tx Phase III trial for the treatment of atrial fibrillation (AF), indicating that 97% of patients had a greater than or equal to 50% reduction in AF episodes, and 50% reported no recurrence. A Phase II study indicated that, at six-month follow up, 87% of 37 patients had a greater than or equal to 50% reduction in AF episodes, and 48% reported no recurrence. Its results were reported in April 2001.

Cardima said it expected to complete the necessary six-month Phase III follow-up last month and plans to submit a premarket approval application in 3Q02. The Revelation Tx is a minimally invasive, single-use system.

Separately, Cardima completed its clinical study in Germany with the Revelation Helix radiofrequency (RF) ablation microcatheter for the treatment of atrial fibrillation (AF) originating in the pulmonary veins of the heart. The study involved 40 patients who were treated at five electrophysiology centers. Results of the study will be presented at this November's American Heart Association (Dallas, Texas) annual scientific sessions in Chicago, Illinois. Cardima said that based on encouraging results, it plans to apply for an investigational device exemption for the Revelation Helix in the U.S. and begin a clinical study in the second half of the year. The Revelation Helix received CE mark approval last December.

Elsewhere in the product pipeline:

Arrow International (Reading, Pennsylvania) completed a preliminary review of clinical data supporting the CE mark application for its LionHeart, an implantable left ventricular assist system. While the LionHeart has accumulated 50% more patient months than called for in the protocol, there is concern regarding the number of mechanically assisted patients in the trial. The company said extending the LionHeart trial for an additional six months, to Dec. 30, will enable 10 to 15 patients to be added to the trial and is expected to increase the number of LionHeart patients living more than one year with the device to eight or more..

Boston Scientific (Natick, Massachusetts) submitted a CE mark application for its Taxus paclitaxel-eluting stent system. The company added that after receiving regulatory approvals in additional countries, it has expanded the commercialization of the Taxus product through the WISDOM transitional registry program. Boston Scientific is conducting the registry in a number of countries as part of a limited commercial launch. "The application for CE mark is further evidence that we are on track to launch in Europe later this year," said Jim Tobin, president and CEO. The TAXUS series of clinical studies, now up to TAXUS IV, is designed to collect data on Boston Scientific's paclitaxel-eluting stent technology for reducing coronary restenosis. The TAXUS IV trial has enrolled 1,172 patients, the target patient number for the trial, and the follow-up period has begun for those patients. Boston Scientific has said it expects to launch paclitaxel-eluting stents in Europe this year and in the U.S. in 2003.

CardioGenesis (Foothill Ranch, California) said clinical data from four studies of transmyocardial revascularization (TMR) performed with its Holmium:YAG laser show it to be effective in producing sustained relief from severe angina in patients suffering from chronic cardiovascular disease. One showed 82% of selected patients experienced "excellent" sustained relief from angina pain with either no angina pain or only Class 1 symptoms at follow-up. Another showed that TMR provided an improved revascularization for the treated patient population, and there was no operative mortality in the patients, all patients were discharged with angina relief and there were no re-admissions for cardiac symptoms.

Cook (Bloomington, Indiana) submitted to the FDA for premarket approval its Zenith AAA Endovascular Graft, a third-generation endovascular graft system that matches the anatomy of patients being treated for abdominal aortic aneurysm (AAA). The system includes features to improve fixation and reduce stent-graft leakage. It has been clinically shown to lower morbidity rates, reduce recovery time and improve quality of life for patients undergoing endovascular AAA repair compared to open surgical procedures.

CryoCath Technologies (Montreal, Quebec) began U.S. sales and commercialization activities of its SurgiFrost Surgical CryoAblation System as its marketing partner, Endocare (Irvine, California), received FDA 510(k) clearance for SurgiFrost. The clearance specifically covers the embodiment of several technologies including a 6 cm probe optimized for creating linear ablations. The SurgiFrost probe is used to ablate cardiac tissue while a patient is undergoing a primary cardiac surgical procedure, such as coronary artery bypass grafting or mitral valve replacement and/or repair. SurgiFrost is a malleable, single-use cryosurgical probe developed to surgically treat cardiac arrhythmias.

Endologix (Irvine, California) demonstrated its PowerLink System during the Paris Course on Revascularization conference on a 66-year-old male suffering from an abdominal aortic aneurysm. He left the operating room after the successful procedure in 24 minutes. The PowerLink System was delivered to the site of the aneurysm through the artery of the leg, eliminating a need for abdominal surgery. Clinicians said the device is the only single-piece system with integral support. Its design provides for rapid delivery, and it adopts a stable position within the aorta thanks to the self-expanding endoskeleton. Endologix recently announced a merger with Radiance Medical Systems (also Irvine). It next plans to enroll and follow its U.S. pivotal study of the PowerLink System, obtain Japanese clearance for the procedure and build sales revenue in Europe.

Endovasc (Montgomery, Texas) was granted U.S. patent No. 6,395,023 B1, its second biodegradable drug delivering stent patent, titled "Prosthesis with Biodegradable Surface Coating and Method for Making Same." Endovasc said the patents represent two of five covering its biodegradable stent/prosthesis technology. Endovasc recently licensed its stent coatings and biodegradable stents to MIV Therapeutics (Vancouver, British Columbia) for $2.2 million plus royalties, and the new patent is included in the license.

Guidant (Indianapolis, Indiana) released six-month follow-up clinical trial results for its Multilink Penta Coronary Stent System. The clinical trial, involving 200 patients with de novo native coronary artery lesions, demonstrated a 17.5% binary restenosis rate. The mean lesion length was 12.9 mm, which is longer than in previous Multilink trials. In addition, more than 83% of lesions were of a complex morphology. Results showed a 99% procedural success rate, accompanied by a 30-day MACE (major adverse cardiac event) rate of 1%. Clinical data reported at the Paris Course on Revascularization suggests that stent and delivery system technology are important in determining the overall performance of drug-eluting stents. Guidant supplies components, including the Multilink Penta stent, to Cook (Bloomington, Indiana) for use in the paclitaxel-eluting Achieve Stent System, currently an investigational device being developed by Cook (see Business Developments, page 10).

Hypertension Diagnostics (St. Paul, Minnesota) introduced at the International Society of Hypertension and the European Meeting on Hypertension in Prague, Czech Republic, its international physician office product, the CVProfilor MD-3000 System. The system is CE-marked and is designed for use in physicians' offices outside the U.S. to noninvasively assess the health of patients' large and small arteries for the early detection and management of vascular disease. The CVProfilor MD-3000 System allows physicians to detect a premature loss of arterial elasticity in the microvasculature, providing new clinical information on the cardiovascular health of patients, expanding vascular disease assessment to include teens and young adults, monitoring the effects that cardiovascular drugs have on vascular elasticity and establishing a baseline for vascular disease risk. Separately, the company said its CardioVascular Profiling System was featured in three abstracts at the World Congress of Cardiology meeting in Sydney, Australia. The PulseWave CR-2000 Research System was described as a well-tolerated, noninvasive tool that has positive predictive power for vascular disease in the general population.

Implant Sciences (Wakefield, Massachusetts) signed a research agreement with the New England Medical Center (Boston, Massachusetts) to conduct a six-month preclinical trial to evaluate drug-eluting and radioactive stents that inhibit coronary restenosis following balloon angioplasty. The research, partially funded by the National Institutes of Health (Bethesda, Maryland), will include evaluation of a drug-eluting microporous polymer-covered stent that was jointly developed by Implant Sciences and CardioTech (Woburn, Massachusetts) for use during coronary artery angioplasty procedures. Implant touts the biocompatible porous polymer membrane that covers its drug-eluting stent as having advantages over those currently available, owing to the tissue ingrowth promoted and the higher drug-delivery capacity of the porous membrane. Preclinical trials will begin soon.

International Technidyne (Edison, New Jersey) said it expects its Protime system to draw more interest as Medicare coverage was recently expanded to include home use of its anticoagulation therapy monitoring system. Heart-valve patients take warfarin and other drugs to prevent formation of blood clots, and monitor prothrombin time (PT) by measuring the International Normalized Ratio (INR). Through a small fingerstick sample, Protime accurately determines if blood coagulation is in the proper therapeutic range. The CMS national coverage decision provides reimbursement for home INR testing up to once per week. Originally introduced in 2001 as a professional-use device, Protime later became the first FDA-cleared system for patient self-testing.

Medical Data Electronics (MDE; Arleta, California) released a single-patient-use Angel Telemetry set, Angel is an all-in-one telemetry set designed with integrated lead wires, electrodes and a battery that provides cardiac monitoring in excess of 72 hours. The complete unit weighs 2.8 ounces. Its waterproof foam housing and fabric-covered lead wires add to patient comfort. As a single-patient use transmitter, no cleaning is required, eliminating concern about infection. Angel operates in the WMTS 608-614MHz medical band, providing a solution for hospitals needing to upgrade their telemetry units to the newly mandated frequency band. MDE is a subsidiary of Viasys Healthcare (Conshohocken, Pennsylvania).

Micrus (Mountain View, California) said that patient enrollment was prematurely discontinued in the International Subarachnoid Aneurysm Trial. The study was halted after early analysis revealed a significantly more favorable outcome of the endovascular therapy treatment, e.g., embolic coiling. A significant subset of patients was treated with its ACT MicroCoil System in the 2,082-patient, randomized, multicenter study designed to compare traditional surgery with endovascular therapy in the treatment of ruptured intracranial aneurysms. An interim analysis of the study will be published in The Lancet.

Orbus Medical Technologies (Fort Lauderdale, Florida) released at the Paris Course on Revascularization its coronary R stent. Clinicians reported that the dual-helix design of the stent enables unparalleled side branch access and radial strength, making it well suited for the treatment of bifurcation lesions. Orbus said one of its future products is the covered R stent. The company called ongoing development work and animal studies "promising." Also at the conference, clinicians reported the first experience with a covered stent in the intracranial circulation. The compassionate-use case involved the implantation of an experimental version of the Orbus covered stent for a life-threatening indication – sealing an 8 mm hole in a major artery of the brain. The patient's life was saved.

Rubicon Medical (Salt Lake City, Utah) presented at the Paris Course on Revascularization its Rubicon Filter embolic filter technology. The Rubicon Filter, which recently completed feasibility testing at the Utah Artificial Heart Institute, is an embolic filter used to treat arterial blockages in the coronary and peripheral arteries. The technology targets an eventual estimated $1 billion worldwide market. The company said that, based on feedback from the conference, it expects its clinical trials and commercialization process will move ahead.

VNUS Medical Technologies (San Jose, California) said a report published in May's Journal of Vascular Surgery shows that endovenous radiofrequency obliteration of saphenous vein reflux (the Closure procedure) is associated with shorter recuperation time, less post-operative pain, faster return to normal activities, and shorter sick leaves compared to traditional vein-stripping surgery. In the Closure procedure, open surgery is avoided and the treatment is performed with local anesthesia and as an outpatient or office procedure. Closure involves a thin catheter that is inserted into a diseased vein to controllably heat the vein, causing it to collapse and seal as the catheter is slowly withdrawn. The catheter is connected to a radiofrequency generator that constantly controls the vein temperature to guide effective therapeutic heating and sealing of the vein. Previously published studies have shown that two years after treatment, 90% of treated legs are free of saphenous reflux and symptoms.

WorldHeart (Ottawa, Ontario) submitted to the FDA a premarket approval (PMA) supplement for use of an expanded polytetrafluoroethylene (ePTFE) inflow conduit as an alternative option for its Novacor left ventricular assist system (LVAS). The inflow conduit carries blood from the natural heart to the Novacor LVAS, which then pumps the blood into the aorta to assist a failing heart. The conduit, which uses ePTFE graft material, was approved in the European Union. WorldHeart said the ePTFE conduit has undergone several design refinements, which have yielded additional structural strength. Earlier, WorldHeart said it would submit to the FDA in 3Q02 a PMA supplement seeking destination therapy indication for its Novacor LVAS. The Novacor LVAS is an electromagnetically driven pump that provides circulatory support by taking over part or all of the workload of the left ventricle.