A Medical Device Daily

Sorin Group (Milan, Italy), a leading developer of devices for the treatment of cardiovascular diseases, reported the enrollment of the first three patients in a clinical trial aimed at obtaining European market approval for its Perceval S Sutureless Aortic Heart Valve.

In a previous first-in-man pilot study, 30 patients at high surgical risk were enrolled in three European centers. The new Perceval S clinical trial will involve some 150 patients at high surgical risk in nine European centers.

The first three implants of the clinical trial were performed at the Institut Mutualiste Montsouris (IMM) in Paris.

"We successfully implanted the first three patients in this important trial. I was able to appreciate the innovative characteristics of the device in terms of safety, procedural success and clinical outcome," said Fran ois Laborde, MD, chief of cardiac surgery at IMM hospital. "This valve allows the removal of the diseased valve, precise positioning and fast release and implantation, and therefore, ultimately a significant reduction of surgical time."

Sorin Group's Perceval S valve is a bioprosthesis made of a bovine pericardial tissue assembled on a super-elastic metal alloy stent. The valve evolved from the Pericarbon Freedom Valve, a well-established Sorin Group pericardial stentless valve that has been sold in Europe since 1991.

Among the benefits cited by the company for the new valve are reduced implantation time vs. conventional stented aortic valves, well-established bovine pericardial valve design, super-elastic metal alloy stent, optimal aortic wall anchoring and sealing, and exclusive detoxification treatment.

"This ... prosthesis is designed to be implanted using a quick metal stent deployment technique, thus obviating the need for using time-consuming, conventional suturing techniques," said Sorin CEO Andr -Michel Ballester.

French system signs Hutchinson accord

Hutchinson Technology (Hutchinson, Minnesota) said it has signed a two-year tender authorizing it to sell its InSpectra StO2 Tissue Oxygenation Monitoring System to the 37 French hospitals belonging to the Assistance Publique Hopitaux De Paris (AP-HP), a healthcare system that admits more than one million emergency patients per year.

The company said InSpectra StO2 is a new vital sign with "broad applications" for critical-care medicine.

The InSpectra StO2 System for tissue oxygenation monitoring helps clinicians reduce risks and costs by enabling faster and more precise assessment of oxygen delivery to vital organs and tissue. The system provides continuous information using near-infrared spectroscopy and a noninvasive, single-use sensor placed on the thenar eminence (thumb muscle).

During shock, the body reduces blood flow to peripheral muscles and core organs (liver, gut and kidneys) in order to preserve oxygenation of the brain and heart. By measuring tissue oxygenation in the peripheral thenar muscle, the InSpectra StO2 System uses the body's own response mechanism to provide information on the adequacy of oxygen delivery to these vital organs.

Rick Penn, president of Hutchinson Technology's BioMeasurement Division, said, "This agreement provides strong validation for the value of non-invasive tissue oxygenation monitoring of critically ill patients. We have put the resources in place to support this opportunity, and we hope to build a strong partnership moving forward."

ESC reaffirms advice on VTE risks

Following a review by The Lancet of the medical issues associated with commercial air travel, the European Society of Cardiology (ESC; Sophia Antipolis, France) has reaffirmed its advice about the risks of venous thromboembolism (VTE), whose risk, according to the Lancet article, is increased "up to four-fold" by long-haul flight.

Dr, Steen Kristensen, vice-president of the ESC, said, "Long-distance flying is associated with an increase in deep venous thrombosis, which in some cases may lead to clotting of the lungs. People who are immobile, pregnant, taking contraceptive pills or have had venous thrombosis in the past are particularly at risk. The use of compression stockings is for some travelers an important way of preventing deep venous thrombosis."

Studies cited by The Lancet suggest that the risk of VTE increases when flight duration exceeds four hours. This raised risk is related to immobility, dehydration, and reduced oxygen in the cabin, as well as to individual risk factors such as obesity, recent surgery and predispositions to thrombosis.

The ESC said it is in the process of preparing a policy statement on the safety of commercial air travel for cardiac patients.

No Comments