Sorin Group Receives Conditional FDA Approval to Conduct IDE Clinical Trial for Perceval (TM) S Sutureless Aortic Valve in the United States
MILAN, Italy--(BUSINESS WIRE)--Apr 29, 2013--Sorin Group, (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today it has received U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application and clinical trial protocol to begin evaluating its PERCEVAL S sutureless aortic tissue valve.
Rakesh Suri (M.D.), Associate Professor of Surgery, Consultant Cardiovascular Surgeon, Mayo Clinic, Rochester, Minnesota, is the Principal Investigator for the PERCEVAL S IDE trial that will involve up to 25 U.S. centers. The purpose of this prospective, non-randomized, multi-center clinical trial is to demonstrate the safety and effectiveness of the PERCEVAL S sutureless heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Aortic stenosis, one of the most common valvular heart abnormalities, is a degenerative disease resulting from a progressive age-dependent build-up of calcium that disrupts blood flow across the aortic valve.
PERCEVAL S is a bioprosthetic valve designed to replace a diseased native or malfunctioning prosthetic aortic valve in patients with aortic stenosis using either traditional or minimally invasive heart surgery. Due to its original characteristic of allowing sutureless positioning and anchoring at the implantation site, the PERCEVAL S aortic valve will offer significant advancements in surgical Aortic Valve Replacement (AVR) technology.
PERCEVAL S is designed to be implanted through either a traditional open heart surgical approach or through a Minimally Invasive Cardiac Surgery (MICS) partial sternotomy or right mini-thoracotomy implantation technique. MICS techniques are increasingly important for AVR because they reduce surgical trauma and morbidity which is an important consideration for the growing number of AVR patients.
After its initial European market clearance in 2011 and more than 2,000 implants, PERCEVAL S has proven to be a revolution in cardiac surgery, optimizing both operating time 1 and clinical outcomes 2.
“We are eager to provide this innovative treatment to a wider patient population in the U.S. and to support the cardiac surgeon community in performing more and more MICS procedures,” said Michel Darnaud, Sorin Group, President, Cardiac Surgery Business Unit.
1 Flameng W, Herregods MC, Hermans H, Van der Mieren G, Vercalsteren M, Poortmans G, Van Hemelrijck J, Meuris B. Effect of sutureless implantation of the Perceval S aortic valve bioprosthesis on intraoperative and early postoperative outcomes. J Thorac Cardiovasc Surg 2011 Dec;142(6):1453-7.
2 Santarpino G, Pfeiffer S,Concistré I, Grossmann M, Hinzmann H, Fischlein TJ. The Perceval S sutureless aortic valve bioprosthesis has the potential of shortening surgical time : Does it also result in improved patient outcome ?. STS 2013 – Scientific Presentation.
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, the Company focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) 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.