A Medical Device Daily

With receipt of the CE mark for the Endeavor Resolute drug-eluting coronary stent (DES), Medtronic (Minneapolis) said it plans to launch the product outside the U.S. sooner than originally expected.

The company said the Endeavor Resolute stent will be launched in more than 50 countries in Europe, Asia, the Middle East and Africa by the end of 2007, making Medtronic the first company to offer two internally developed drug-eluting stent options for the treatment of coronary artery disease. The new DES is not yet approved in the U.S.

The company said the Endeavor Resolute “leverages the strengths of the Endeavor” DES, which was launched in Europe in July 2005 and is now available in more than 100 countries outside the U.S. They share the same cobalt alloy stent platform which, the company said, “provides excellent radial strength and conformability to the vessel wall,” and both use the non-cytotoxic drug zotarolimus.

In addition to the Endeavor Resolute and Endeavor DES devices, Medtronic offers the Driver bare-metal stent (BMS).

“The Endeavor Resolute drug-eluting stent and the BioLinx polymer represent two important achievements of our product pipeline and demonstrate our commitment to innovation in interventional cardiology,” said Scott Ward, president of Medtronic’s cardiovascular business. “With the combination of Driver, Endeavor and Endeavor Resolute, [we are] delivering safe and effective options for physicians to treat a broad range of patients with coronary artery disease.”

Endeavor Resolute uses a biocompatible polymer called BioLinx, which the company said is designed to confer the same biocompatibility as the Endeavor stent’s phosphorylcholine polymer while extending the duration of drug exposure in the vessel.

Developed by Medtronic scientists, BioLinx is the first polymer created specifically for DES use. “The BioLinx polymer features a unique blend of hydrophilic and hydrophobic elements for optimal performance,” the company said in a statement.

It said extensive preclinical studies have established the biocompatibility and drug delivery capabilities of the BioLinx polymer.

Dutch cardiologist Patrick Serruys, MD, performed the first commercial implant of the Endeavor Resolute stent at the Heartcenter Rotterdam on Oct. 10. “We now have a new drug-eluting stent for our patients with a breakthrough in coating technology,” he said.

“Endeavor Resolute provides the excellent safety profile of the Endeavor stent with extended delivery of the drug zotarolimus,” Serruys said. “To further evaluate the safety and efficacy of the new stent in real-world clinical practice, we have designed a post-market European study involving more than 2,300 patients.”

Patients treated with the Endeavor Resolute DES in the initial RESOLUTE clinical trial required no repeat procedures through nine months and had experienced no protocol-defined stent thrombosis through 12 months of follow-up. In-stent late lumen loss at nine months, the study’s primary endpoint, was met, providing assurance of vessel healing in the targeted range and avoiding repeat procedures.

Among the trial’s 130 patients, only one required clinically-driven target lesion revascularization or target vessel revascularization through 12 months. The incidence of major adverse cardiac events was 8.5% through 12 months.

The 12-month results from RESOLUTE were available in abstract form at this week’s Transcatheter Cardiovascular Therapeutics meeting in Washington.

“The RESOLUTE clinical results are impressive considering the enrolled patients presented with especially complex and challenging characteristics,” said the trial’s principal investigator, Ian Meredith, MD, of Monash Medical Center (Melbourne, Australia).

Medtronic said it plans additional ctrials of the Endeavor as part of a program to characterize ong-term safety/efficacy in various patient populations. The program will enroll about 13,000 patients in a series of randomized controlled trials and registries in the U.S. and internationally.

MGuard stent receives CE mark

In other stent news, InspireMD (Tel Aviv, Israel) also reported receiving CE-mark approval for its MGuard Coronary Stent, clearing the way for marketing in Europe, Latin America, Asia and Africa.

“This is a major achievement for InspireMD,” said Ofir Paz, CEO and chairman. “MGuard receives the ‘green light’ to compete in a market worth more than $3 billion annually. Designed to enhance the safety of stenting procedures, we are confident that MGuard Coronary provides advantages over other available coronary stents and is well positioned to capture a significant share of this large and growing market.”

The MGuard Coronary stent presents a combination of a coronary stent merged with an embolic protection device. The embolic protection device is comprised of an ultra-thin polymer mesh protective sleeve, wrapped around the stent.

The protective sleeve is composed of a micron-level-fiber knitted mesh, engineered in a geometric configuration and designed, the company said, “for utmost flexibility while retaining strength characteristics of the fiber material.” The sleeve is designed to expand seamlessly when the stent is deployed, without affecting the structural integrity of the stent, and to prevent plaque detachment during and post procedure.

InspireMD said the MGuard stent provides “long-acting embolic protection, without adding complexity in deliverability. The sleeve is designed to diffuse stent pressure on the vessel wall, thereby may reduce injury and lower the likelihood of restenosis.”

In ongoing clinical trials in Germany, the MGuard Coronary has achieved a procedural success rate of 100% with no report of any major adverse cardiac events, the company said.

Dr. Asher Holzer, InspireMD president, said, “Cardiologists around the world are excited about the product, its concept and its applicability in a variety of coronary stenting procedures. We have already received pre-launch orders valued at over $1.5 million, and the CE mark paves the way to generate significant sales volume and wide market adoption of our proprietary stent platform technology.”

InspireMD said it will pursue applications of the MGuard technology both for BMS and DES devices in coronary, carotid and peripheral artery procedures.