Healthcare Industry News:  valve repair 

Devices Cardiology Regulatory

 News Release - November 25, 2013

Sorin Group Announces CE Mark Approval for the XL Version of the Perceval(TM) Sutureless Aortic Valve

Perceval ‘size XL’ expands the number of patients that can benefit from a sutureless aortic valve replacement

MILAN--(Healthcare Sales & Marketing Network)--Sorin Group (SRN.MI), (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, announced today it has received CE (Conformité Européenne) Mark approval for the XL version of Perceval.

Perceval is a bioprosthetic device designed to replace a diseased native or malfunctioning prosthetic aortic valve using either traditional or minimally invasive heart surgery. Perceval implant is easy(1), safe(1,2) and reproducible(3) due to the unique technology that allows sutureless positioning and anchoring at the implantation site. This approval expands the Perceval portfolio, permitting cardiac surgeons to treat patients with annulus sizes ranging from 19 mm to 27 mm.

A recent published retrospective observational study of 137 patients(3) shows operating time reduction, no intra-operative mortality, shorter Intensive Care Unit (ICU) and hospital stay (a median of 1 and 7 days respectively). The authors conclude that Perceval used in minimally invasive aortic valve replacement is a feasible, effective and safe device.

Positive health economic results were recently presented by Lorenzo Pradelli, M.D. at AdRes and Marco Ranucci, M.D. at S. Donato Hospital (Milan, Italy) during the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) congress (Berlin, Nov 2-6, 2013). The authors concluded that the choice to implant Perceval, thanks to the savings in operating time for suturing, is expected to improve clinical outcomes and to lower operating and complication costs.

“We are consistently achieving key milestones regarding the Perceval platform. Patients with XL sizes represent a considerable percentage of the eligible population for Aortic Valve Replacement, therefore, our additional size is a great opportunity to treat patients with the latest therapies,” said Michel Darnaud, President, Cardiac Surgery Business Unit, Sorin Group.

1)Santarpino et al. Ann Thorac Surg. 2013;96(1):77-81.

2)Santarpino et al. Ann Thorac Surg. 2012; 94:504.

3) Gilmanov et al. MMCTS. 2013; mmt012 doi: 10.1093/mmcts/mmt012

About Sorin Group

Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,750 employees worldwide, Sorin Group focuses on. two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement prostheses) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose arrhythmias and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment) Every year, over one million patients are treated with Sorin Group devices in more than 80 countries.

For more information, please visit www.sorin.com.


Source: Sorin Group

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