News | March 17, 2009

Enrollment Begins for Sorin Sutureless Aortic Valve in Europe

March 17, 2009 – Sorin Group recently announced 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 centers throughout Europe.

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 Professor François Laborde, chief of cardiac surgery at the 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,” he added.

The Sorin Group Perceval S Sutureless Aortic Heart Valve is a bioprosthesis made of a bovine pericardial tissue assembled on a super-elastic metal alloy stent. Building on the Pericarbon Freedom Valve, a Sorin Group pericardial stentless valve on the European market since 1991, the Perceval valve features a unique stent design.

The design allows implantion using a quick metal stent deployment technique to avoid using time-consuming, conventional suturing techniques.

The company says key benefits of the Perceval S valve include reduced implantation time, use of a well-established bovine pericardial valve, super-elastic metal alloy stent, optimal aortic wall anchoring and sealing, and a detoxification treatment.

For more information:

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Overlay Init