A Medical Device Daily

Boston Scientific (Natick, Massachusetts) said it has received indication extensions to the European CE mark for its Taxus Liberté paclitaxel-eluting coronary stent system for use in what it characterized as “some of the most challenging coronary procedures.”

The new labeling reflects a review of Taxus clinical data by the European regulatory agency. In addition to its existing indication for the treatment of de novo lesions in native coronary arteries, the Taxus Liberté system is now indicated in Europe for the treatment of restenotic lesions (in-stent restenosis, or ISR) and total occlusions (TO) in patients with coronary artery disease, including acute myocardial infarction (AMI). These three new indications account for more than 20% of all coronary interventions.

Boston Sci said the Taxus Liberté stent system is now the only drug-eluting stent system with these new indications for use in Europe.

This revised labeling follows what Boston Scientific called “the excellent clinical outcomes the Taxus stent system has shown in the treatment of complex lesions in recent clinical trials and registries, including the TAXUS V ISR trial and the MILESTONE II, WISDOM, ARRIVE, and OLYMPIA registries.”

In addition to the three new indications, the large-vessel diameter Taxus Liberté stent also received the CE mark. The company said this stent uses a modified cell design intended for drug delivery in larger vessels, and will be available in a 4 mm diameter and seven different lengths.

“The European approval for new indications recognizes the strong long-term performance of the Taxus stent system across complex patients and lesions,” said Jeff Goodman, president of Boston Scientific International.

New training facility planned

Boston Scientific also reported plans to construct a new medical training facility in Brussels, Belgium, designed to help healthcare professionals advance the standard of patient care. The company said it expects the new addition to be completed in early 2007.

The training facility will be able to host thousands of healthcare professionals annually and will offer medical education and skills training on the latest developments in the medical device field.

Originally founded in 2000 by Guidant (Indianapolis), the Institute for Therapy Advancement is, according to Boston Sci, “a leader in medical education programs that address the real-world practical needs of healthcare professionals.”

It is now part of a Boston Scientific global medical education network with campuses in Brussels, Tokyo and St. Paul, Minnesota. Boston Scientific acquired Guidant on April 21.

“From our work at the Institute for Therapy Advancement over the past five years, we have learned which type of training is important,” said Professor Jean Marco of the Institute Pasteur (Toulouse, France). “This experience is a guide to building a second-generation institute that better addresses the specific needs of medical professionals at all levels.”

“This new Institute for Therapy Advancement facility is a reflection of our commitment to helping physicians put into practice the latest developments and guidelines,” said Jeff Goodman, senior vice president and president of Boston Scientific's International business unit. “We understand that time is a scarce resource for clinicians today so the effectiveness and efficiency of continued medical education has become increasingly important.”

More than 15,000 healthcare professionals have participated in the institute's programs to date.

New driver for artificial heart

Berlin Heart (Berlin), maker of the Excor ventricular assist devices for children and adults, has received the CE mark to market a modified version of its Excor Mobile Driving Unit with the CardioWest TAH-t in Europe.

The TAH-t, manufactured by SynCardia (Tucson, Arizona), is the only FDA-, Health Canada- and CE-approved artificial heart in the world. The device is a bridge to transplant for patients with end-stage biventricular heart failure who are waiting for a donor human heart. The pneumatic drivers provide air pulses that make the TAH-t pump blood much like a human heart.

The new Excor TAH-t portable driver is about the size of an attaché case and weighs only 20 pounds, SynCardia said. It is designed for use following TAH-t implant surgery, by stable patients. The portable driver allows stable patients to recover at home, which speeds recovery, improves quality of life and dramatically lowers costs, the company said.

In addition, the portable driver enables patients to leave home to shop, and for some, to travel.

The older, 400-pound, washing machine-sized driver, “Big Blue,” is used both in the operating room and the hospital. Using “Big Blue” to power the TAH-t requires patients to remain in the hospital until a donor heart is found. In Europe, that could take up to two years.

“The portable driver gives patients more freedom to enjoy a better quality of life . . . and because many patients recuperate in the comfort of their homes, hospitalization costs for this portion of their recovery are eliminated,” said cardiologist Marvin Slepian, MD, chairman of SynCardia.

SynCardia has applied for its own CE mark, which will allow the company to market its TAH-t with the Excor TAH-t in Europe, and anticipates approval in the current quarter. The TAH-t is a modern version of the Jarvik-7 Artificial Heart that was implanted in Barney Clark in 1982. In the 1990s, the device and technology moved to University Medical Center (UMC; Tucson) and was subsequently renamed the CardioWest temporary Total Artificial Heart.

Budget cutbacks at UMC came close to stopping the study of the technology. To save the TAH-t, SynCardia Systems was formed in 2001 by Slepian, Richard Smith and cardiovascular surgeon Jack Copeland, MD.