News | February 01, 2011

Self-Anchoring Aortic Heart Valve Receives CE Mark

February 1, 2011 – A self-anchoring aortic heart valve has received the CE mark. With the approval, the Perceval S Sutureless biological valve, by the Sorin Group, is now commercially available in Europe.

It is indicated for the rapid and minimally invasive surgical replacement of the aortic valve in patients suffering from aortic stenosis. Aortic stenosis is the most common acquired valvular heart disease in the Western world and its occurrence increases with age. The prognosis is poor for patients with severe symptomatic aortic stenosis. If the patient remains untreated after symptoms appear, the average survival is short – often only two to three years.

The surgical aortic valve has a self-anchoring frame that enables the surgeon to replace the diseased valve without suturing it into place. The valves’ functional component is made of bovine pericardium and is mounted on a super-elastic alloy frame. The system builds on a clinically proven stentless aortic pericardial valve implanted in over 10,000 patients with proven durability and optimal hemodynamics. Clinical results in the first 180 patients show a significant reduction in surgical procedural time for both isolated and complex aortic valve replacement. Aortic cross-clamp times typically reduced by at least 50 percent.

The hemodynamic performance was outstanding with low pressure gradients and large effective orifice areas at one and two years follow-up. To date, 25 cardiac surgery centers throughout Europe have implanted the Perceval S valve in over 500 total patients as part of the pre-commercialization clinical studies.

For more information: www.sorin.com

Related Content

CMS considers eliminating cardiac bundled payments.
Feature | Business| August 16, 2017 | Dave Fornell
August 16, 2017 — The Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to reduce the number
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-...
The ChordArt transcatheter mitral valve leaflet chord replacement system on X-ray, showing the anchoring sections of the artificial chord.

The ChordArt transcatheter mitral valve leaflet chord replacement system on X-ray, showing the anchoring sections of the artificial chord.

News | Heart Valve Technology| August 01, 2017
Aug.
Sponsored Content | Videos | Peripheral Artery Disease (PAD)| July 25, 2017
This video case study, provided by Gore Medical, is titled "Tackling Complex Cases in Dialysis Access," by John Ross,
Hitachi and West Virginia University Partner to Advance Left Ventricular Mechanical Function Evaluation
News | Cardiovascular Ultrasound| July 21, 2017
Hitachi Healthcare and the West Virginia University Heart and Vascular Institute announced the formation of a new...
Sponsored Content | Videos | Cardiovascular Surgery| July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Edwards Sapien 3 TAVR valve will be implanted in asymptomatic aortic stenosis patients in the EARLY TAVR Trial
Feature | Heart Valve Technology| July 14, 2017
July 14, 2017 — Morristown Medical Center, part of Atlantic Health System, has randomized the first patient in the wo
Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve

An example of Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve.

Technology | Computed Tomography (CT)| July 12, 2017
July 12, 2017 — At the 2017 annual meeting for the Society of Cardiovascular Computed Tomography (SCCT), Ziosoft show
Overlay Init