A Medical Device Daily Global cardiovascular device maker Sorin Group (Milan, Italy) and Orange Business Services (Paris), a communications solutions integrator, reported reaching an agreement to develop and service a remote monitoring solution for patients implanted with cardiac rhythm management (CRM) devices.

Orange is the main brand of France Telecom. With 123 million customers, the brand now covers Internet, television and mobile telephone services in the majority of the 30 countries where the group operates.

The planned new solution is based on Sorin's implanted CRM devices' ability to send data to a non-invasive monitoring system located at the patient's home and on Orange Business Services' capabilities to manage the transmission of the data to the physician.

The solution will facilitate the follow-up care of patients by transmitting data electronically from patients' implanted cardiac devices to their physicians, without the patients leaving their homes.

Using such data, physicians can detect arrhythmia or cardiac disease progression and provide timely therapy, which may reduce the need for hospitalization and improve the patients' quality of life.

Managing a growing number of patients implanted with CRM devices, as well as the related follow-up, is increasingly demanding for clinicians, Sorin said. The introduction of a remote monitoring system, which provides caregivers access to comprehensive data recorded by the implanted device while the patient is at home, "represents a significant milestone in patient management," it said.

The company said the algorithms and data embedded into its pacemakers, defibrillators and cardiac resynchronization devices provide caregivers with specific information regarding the device behavior and the patient's condition. "These diagnostic capabilities will enable transmission of valuable alert messages, providing clinicians with relevant information and offering patients more peace of mind," Sorin said in a statement.

"Our strategy is to work with acknowledged leaders in other industries," said Stefano Di Lullo, president of Sorin's CRM Business Unit. "We are delighted to have signed this collaborative agreement with Orange Business Services, a leading global integrated operator providing pioneering telecommunications services on a worldwide basis."

Thierry Zylberberg, head of Orange Healthcare, said, "Sorin Group's advanced medical technologies and innovative therapeutic solutions, combined with Orange's expertise in application and program management for large, complex projects, will result in a solution that increases options to raise the quality of healthcare."

CE mark for Xtent's Custom NX system

Xtent (Menlo Park, California) reported receipt of the CE mark for its Custom NX drug-eluting stent (DES) system.

The approval, which allows the Custom NX system to be marketed in the European Union and other countries that recognize the CE mark, includes both the Custom NX 36, a 36 mm stent and the Custom NX 60, a 60 mm stent.

"Receipt of the CE mark is an important accomplishment and a validation of the strength of our clinical data," said President/CEO Gregory Casciaro, "It is a tribute to the hard work and dedication of our people as well as the collaborative effort of our drug coating provider, Biosensors."

The CE-mark approval of the system represents a number of "firsts," said Xtent, including:

— Approval of the first ever customizable stent system.

— Approval of the Custom NX 60, the longest coronary stent system ever to be approved for sale.

— Approval of the first stent system to allow treatment of multiple lesions using one catheter.

— Approval of the first stent system to incorporate a post-dilation feature on the delivery catheter.

The Custom NX delivery system allows physicians to customize the length and diameter of the stent at the site of the lesion. The stent is coated with Biolimus A9TM and the biodegradable drug carrier, PLA.

Xtent has completed four clinical trials, with follow-up data up to four years.

Stentys adds AMI to indications

Stentys (Paris) reported that it has extended its self-expanding and disconnectable technology platform to include a second major indication, acute myocardial infarction (AMI). Two patients were treated during AMI procedures last week by Drs. S. Verheye (Antwerp, Belgium) and K.E. Hauptmann (Trier, Germany).

The Stentys platform has two features self-expansion and disconnectability that are designed to be "unrivaled in the stent industry," according to the company.

It said the self-expanding feature "insures optimal apposition in the critical initial hours and days after the procedure by being constantly applied to the vessel surface during thrombus and vessel spasm relief, therefore avoiding malapposition, a significant concern to cardiologists."

The disconnectability feature is designed, the company said, to treat lesions close to a bifurcation, by ensuring safe main branch provisional stenting and optimal side branch access when needed.

The Stentys platform is implanted by usual stenting techniques, requiring no additional training.

"The Stentys device was simple to implant, conformed snugly to the treated vessel, and created minimal vessel injury since no high-pressure inflation was required," said Verheye. "When comparing immediate and five days post-procedure results using IVUS, the coronary vessel expanded slightly, and Stentys followed intimately the vessel remodeling with perfect apposition."

Edwards says German court backs it

Edwards Lifesciences (Irvine, California) reported that the District Court of D sseldorf, Germany, has determined that the company does not infringe on Cook's (Bloomington, Indiana) German transcatheter valve patent.

"We are very pleased with this first infringement decision and believe our invalidity case is even stronger," said Larry Wood, Edwards' corporate vice president for transcatheter valve replacement. "Edwards has invested substantially to assemble what we believe is the strongest and most comprehensive intellectual property portfolio in transcatheter heart valves, and we are committed to protecting our interests."

A countersuit by Edwards claiming invalidity of Cook's German patent is expected to be heard in Munich in 2010.

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