Boston Scientific Completes Enrollment in BEACH CAS Trial

Boston Scientific Corporation (Natick, MA) has completed enrollment in its BEACH clinical trial, an evaluation of the benefits of carotid stenting in conjunction with embolic protection. The single-arm, prospective, nonrandomized trial has enrolled 747 patients at 47 US sites. The devices used in the trial are Boston Scientific’s FilterWire EZ Embolic Protection System and its Carotid Wallstent Monorail Endoprosthesis.

“We are pleased to complete the enrollment phase of this landmark trial,” said Christopher White, MD, Chairman of the Department of Cardiology and Director of the Ochsner Heart and Vascular Institute in New Orleans, and a Co-Principal Investigator of the BEACH trial. “The device combination is highly compatible and facilitates delivery.”

Cook Launches Zilver 518 Biliary Stent COOK

Cook Incorporated (Bloomington, IN) has announced the availability of its Zilver 518 Biliary Stent, which the company describes as a flexible, self-expanding nitinol design intended to treat patients with malignant neoplasms in the biliary system. The device is 5 F-compatible and is delivered over an 0.018-inch guidewire to facilitate use in smaller lumens. The Zilver 518 also features multiple gold radiopaque markers at each end to enhance visibility under fluoroscopy, as well as strong, equally distributed radial force, kink-resistance, and durability, the company states.

Study Shows Possible Link of Obstructive Sleep Apnea to Thoracic Aorta Dissection

Physicians in Barcelona recently concluded a study investigating the association between obstructive sleep apnea syndrome (OSAS) and aortic dissection; the study, which was published in the American Journal of Respiratory and Critical Care Medicine, determined that patients with thoracic aorta dissection ?presented a high prevalence of previously undiagnosed and frequently severe OSAS.? Two cohorts were examined: the first was a group of 19 consecutive patients with thoracic aorta dissection; the second consisted of 19 hypertensive patients of similar age, sex, and body mass index.

All patients were studied by clinical questionnaire and polysomnography, which indicated that snoring and nonrefreshing sleep were common in both groups. The investigators found that although 13 patients from each group showed an apnea-hypopnea index of more than 5 per hour, patients from the dissection group had an index of 28, whereas patients in the control showed an index of 11. Seven of the 19 patients in the study group had an index of more than 30 versus only one patient in the control group. The investigators cited the need for further studies, and commented that in patients with dissection and OSAS symptoms, a sleep study should be considered.

Cordis Announces 15,000-Patient Drug-Eluting Stent Registry

Cordis Corporation (a Johnson & Johnson company, Miami, FL) will soon initiate the D.E.S.cover Registry, which will include approximately 15,000 patients at more than 200 US hospitals. Consecutive patients treated with drug-eluting stents, bare-metal stents, and balloon-angioplasty will be enrolled and followed for at least 12 months posttreatment.

“This landmark study is intended to yield a real-world ‘snapshot’ of the impact of drug-eluting stents on today’s practice of interventional cardiology,” commented Principal Investigator David O. Williams, MD, of Brown University and Rhode Island Hospital. According to Dennis Donohoe, MD, Vice President of Clinical and Regulatory Affairs at Cordis Corporation, the registry will capture a wide range of information about current interventional cardiology practices and procedures, including extensive clinical performance and safety findings as well as health-economic and patient quality-of-life data. Late last month, Cordis invited participating physicians to provide input into the final registry design.

Guidant Introduces ABSOLUTE .035 Biliary Stent

On January 21, Guidant Corporation (Indianapolis, IN) announced the FDA 510(k) clearance of its ABSOLUTE .035 Biliary Self-Expanding Stent System. The company states that this new system improves on its previous generation of 0.035-inch noncoronary stents with better visibility and an easier-to-use delivery system. Tony Das, MD, of the Presbyterian Heart Institute in Dallas also noted these improvements, commenting, ?The stent tracks without hesitation during the procedure, and I was able to deploy it exactly at the target site with perfect precision. I found that it gives me the ability to place a self-expanding stent more accurately even in tortuous anatomy.?

Having also received CE marking for the device, Guidant will be simultaneously launching it in the US and Europe.

FDA Clears IntraLuminal’s Safe-Cross Total Occlusion Crossing System

After having received 510(k) clearance from the FDA, IntraLuminal Therapeutics, Inc. (Carlsbad, CA), is set to launch its Safe-Cross Total Occlusion Crossing System sometime in the first quarter of 2004. The Safe-Cross System is designed to give the interventionist real-time feedback as to the proximity of the crossing wire to the arterial wall, and also to provide the capability of using RF power on the tip of the wire to assist in penetrating hardened material within the artery. The company states that these capabilities facilitate safe and successful passage and placement of therapeutic devices for recanalization of coronary and peripheral total occlusions.

Endologix Submits PMA for Its PowerLink AAA Device

On January 8, Endologix, Inc. (Irvine, CA), reported that it had filed its completed pre-market approval (PMA) submission with the FDA for its PowerLink System. The PowerLink System is an endoluminal stent graft for treating abdominal aortic aneurysms. Endologix states that the completed PMA application includes the clinical results from its pivotal trial as the final step in the modular submission process.

Endologix anticipates receiving FDA approval for marketing the PowerLink System in the US in the second half of 2004. “Over the next 45 days, the FDA must determine that all the necessary components of the submission are included and that the application is ‘fileable,’ “said Paul McCormick, President and CEO of Endologix. “Once deemed fileable,” he continued, “the review of the clinical data will begin and [Endologix] will work with the [FDA] to answer any queries prior to the FDA’s determination of the need for a panel meeting.” Mr. McCormick also commented that two of the four previously submitted modules have already been reviewed and accepted, and that queries regarding the remaining two modules will be addressed during the final PMA review period. “We believe the data submitted is not materially different than that which has been previously reported, and we are confident that we will achieve our goal of gaining US marketing approval for the PowerLink System in 2004.”

At the September 2003 TCT conference, Jeffrey Carpenter, MD, Professor of Surgery at the University of Pennsylvania, presented the preliminary pivotal results from 154 patients who were implanted with the PowerLink System and monitored for at least 1 year. These results include safe deployment in 151 patients (98%) and no device-related aneurysm ruptures, wire fractures, or material failures reported during the follow-up period.

Boston Scientific’s Liberte Coronary Stent Receives CE Mark

Boston Scientific Corporation (Natick, MA) recently announced the CE Mark approval of its Liberte coronary stent. The company plans to launch the device immediately in Europe and other international markets, with a US launch anticipated in the second half of 2004. Paul LaViolette, Boston Scientific’s Senior Vice President and Group President, Cardiovascular Group, has commented that the Liberte device is simultaneously the company’s next-generation bare-metal stent and the platform for its next-generation drug-eluting stent.

GenVec, Cordis Enter Research Collaboration

GenVec, Inc. (Gaithersburg, MD), recently announced that it has entered into a research collaboration with the Cordis Cardiology Division of Cordis Corporation (a Johnson & Johnson company, Miami, FL) to study the clinical benefit of BIOBYPASS, Genvec’s cardiovascular product candidate, in a procedure involving guided delivery of the angiogenic agent directly into targeted regions of the heart in patients with severe coronary artery disease. The procedure utilizes Cordis’ NOGASTAR Mapping Catheter and MYOSTAR Injection Catheter. GenVec states that the purpose of the collaboration is to conduct a European, multicenter, randomized, double-blind, placebo-controlled study of BIOBYPASS. BIOBYPASS produces the angiogenic protein VEGF-121, which has been shown preclinically to stimulate vessel formation in ischemic tissue, the company reports.