A Medical Device Daily

Abbott Laboratories (Abbott Park, Illinois) reported receiving CE-mark approval for a 2.25 mm version of its Xience V everolimus-eluting coronary stent system that it said offers physicians a smaller stent “based upon the proven efficacy and excellent deliverability of Xience V.”

The company said the addition of the 2.25 mm stent to the Xience V portfolio “gives physicians access to a wider range of stent sizes for treating a variety of patient types.”

Charles Simonton, MD, divisional VP, medical affairs and chief medical officer of Abbott Vascular (Redwood City, California), said, “With Xience V 2.25 mm, physicians now have access to a smaller stent that combines [key] attributes with the safety outcomes we have seen with Xience V.

The 2.25 mm stent will be launched immediately in the majority of European markets and select countries in Asia and Latin America.

In addition to the 2.25 mm stent, Xience V is available in diameters of 2.5 mm, 2.75 mm, 3.0 mm, 3.5 mm and 4.0 mm for lesions 28 mm or shorter.

From 30% to 40% of coronary lesions occur in arteries 2.5 mm or less in diameter.

Xience V was launched in Europe and other international markets in late 2006. It is under review by the FDA.

Abbott also supplies a private-label version of Xience V to Boston Scientific (Natick, Massachusetts) called the Promus. That stent is designed and manufactured by Abbott and supplied as part of a distribution agreement between the two companies.

MGuard is launched in Italy

InspireMD (Tel Aviv, Israel) said it has launched the MGuard Coronary Stent in Italy. MGuard received CE-mark approval in October to treat patients with coronary artery diseases. Distribution of MGuard in Italy will be carried out by InspireMD’s Italian distributor, Kardia (Milan).

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 designed 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.

Concomitant with the launch in Italy, MGuard was implanted in a procedure broadcasted live to the more than 1,500 attendees on the opening day of the JIM conference in Rome. The patient was a 71-year-old male suffering from hypertension. The procedure was performed by Dr. Ralf Müller at the Helios Heart Center (Siegburg, Germany).

The MGuard coronary stent is designed to provide an embolic shower protection during and post stenting procedure. In ongoing clinical trials conducted in Germany and Brazil, the MGuard stent has achieved a procedural success rate of 100%, with no major adverse cardiac events.

On the second day of JIM, Antonio Colombo, MD, jointly with Dr. Jeffrey Moses, MD, treated a 76-year-old male patient with progressive infarct myocardium angina. In the procedure, broadcast from San Raphael Hospital (Milan), MGuard was delivered in what the company termed “an extremely complex procedure” involving six different lesions and total of seven drug-eluting stents deployed.

“MGuard represents a very clever approach to embolization control,” Colombo said, “Its safety profile, coupled with the embolic protection during and post-procedure, position MGuard as an important addition to the arsenal of the interventional cardiologist in treating embolization-prone lesions.”

Joshua Reichert, VP, marketing & sales at InspireMD, said, “Interventional cardiologists in Italy and abroad are eager to implement this approach in a variety of lesions and indications. Together with our partner Kardia, we are confident that MGuard is well-positioned to capture a significant share of the stent market in Italy.”

Expanded clinical program for CircuLite

CircuLite (Hackensack, New Jersey) said it has advanced its Synergy Pocket Circulatory Assist Device clinical program into a 20-patient trial designed to lead to CE-mark approval for long-term implantation in heart-failure patients.

This follows successful completion of a first-in-man pilot study of Synergy in four patients. Synergy is a micro implantable blood pump, the size of a AA battery, that can be implanted superficially in a “pacemaker-like” pocket. The device provides long-term, partial circulatory support in patients with chronic heart failure.

Paul Southworth, president/CEO, said, “We believe Synergy represents a potential breakthrough for the long-term support of patients with chronic heart failure who remain symptomatic despite optimal medical management, and, if eligible for a heart transplant, may need to wait more than 12 months for the procedure.”

The European registration trial is planned to enroll 20 patients with chronic heart failure and will evaluate the safety and quality-of-life improvements associated with device support of longer than six months.

Seven patients have been implanted, with six implants performed by Bart Meyns, MD, PhD, at Gasthuisberg University Hospital (Leuven, Belgium), the site of the first-in-man trial. Another patient was implanted at Hannover Medical School in Germany by Drs. André Simon and Martin Strüber.

A third trial site, University Hospital (Münster, Germany), has completed training and is now screening patients for the CE-mark trial.