SORIN-GROUP

Sorin Group (MIL:SRN) (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced the presentation of data demonstrating improved clinical outcomes after use of the next-generation Perceval sutureless aortic valves in European patients with severe aortic stenosis. The findings were presented in three oral presentations at the 95^th Annual American Association of Thoracic Surgery (AATS) Meeting held from April 25 to April 29, in Seattle, USA.

The first set of findings, presented by Prof. Claudio Muneretto from University of Brescia Medical School, Italy, demonstrated significantly greater rates of short and mid-term survival among 991 patients with severe aortic stenosis and an intermediate-high risk profile (STS Score: 4-8%) after treatment with conventional surgery or sutureless valve replacement compared to Trans-Catheter Aortic Valve Replacements (TAVR). The second study “The rise of new technologies for aortic valve stenosis: a propensity-score analysis from two multicenter registries comparing sutureless and trans-catheter aortic valve replacement ” presented by Dr. Augusto D’Onofrio showed that Perceval valves had better device success and a lower rate of mild paravalvular leakage (PVL) when compared to TAVR in patients with severe symptomatic aortic stenosis, and the third one, “First Large Cohort with a Sutureless Aortic Valve: The 1 Year Follow-Up of 628 Consecutive Patients from an International Multicenter Prospective Trial ” presented by Prof. Theodor Fischlein, Nürnberg, confirmed the safety and effectiveness of the Perceval Sutureless aortic valve at 1 year in a prospective, non-randomized, multi-center study.

Prof. Muneretto presented the results of an independently conducted 991-patient multicenter propensity-score analysis based on the therapeutical strategy: sutureless AVR with Perceval, TAVR and conventional surgery (sAVR).

The 30-day mortality rate was 5.8% among patients treated with sutureless valve replacement compared to 9.8% for those who received TAVR and to 3.4% for sAVR. Overall survival rates at 24 months were 94.9±2.1% in the sutureless valve group, 79.5±4.3% in the TAVR group and 91.3±2.4% in the sAVR group. Sutureless valves were also associated with lower rates of postoperative complications, including peripheral vascular complications at 30 days (0% in sutureless and sAVR groups compared to 9.8% in TAVR group) and higher rates of patients who were free from major adverse cardiac and cerebrovascular events and periprostetic regurgitation at 24 months (96.0% in the sutureless valve group compared to 77.1% in the TAVR group and 92.6% in the sAVR group).

“These results demonstrate that for intermediate-high risk patients, Perceval valve is associated with lower rates of mortality and postoperative complications compared to TAVR,” said Professor Claudio Muneretto, M.D.,Ph.D., Director of the Department of Cardiac Surgery at the University of Brescia Medical School in Brescia, Italy.

Dr. Augusto D’Onofrio, from University of Padua, Italy, presented findings from a separate propensity-score analysis of two multicenter registries including 2,175 patients (292 underwent isolated AVR with Perceval and 1,885 TAVR). In the overall cohort before matching, mild PVL was 1.7% in the sutureless cohort versus 31.8% in the TAVR patients. After propensity matching, TAVR patients were more likely to show less device success and more postoperative PVL, even though this was not evident in transapical TAVR.
In the Late-Breaking Clinical Trial section, Prof. Fischlein, from the Department of Cardiac Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany, presented the 1 year results of the CAVALIER trial. This prospective, multi-center study was conducted in a cohort of 628 implanted patients to demonstrate the safety and effectiveness of the Perceval Sutureless aortic valve.
The results showed that, despite the fairly old population (40% octogenarians) with an intermediate patient risk profile (STS Score 7.2%), the overall clinical outcomes at 1 year are very promising, with a low rate of cardiac mortality, stroke, major paravalvular leak, valve explants, and no incidents of valve migration, valve thrombosis, or structural valve deterioration. The patient clinical status improved and remained stable throughout follow up.

“We’re committed to bringing advanced state-of-the-art treatment options to patients with critical unmet cardiovascular needs, and study results continue to reinforce the clinical evidence of Perceval valves,” said Michel Darnaud, President, Cardiac Surgery Business Unit. “Perceval valves have shown to enhance physician and patient experience during surgery, through reduced cross clamp time and shorter required stays in the ICU, and are also associated with improved short and mid-term outcomes over TAVR for aortic stenosis patients who are considering alternatives to conventional surgery. A recent study, reporting the widest and longest follow-up study of sutureless valves published to date, also demonstrates that Perceval is safe and efficacious up to five years, showing promising results also versus standard AVR.¹ ”

The Perceval sutureless biological valve represents one of the latest innovations in heart valve technology from a long line of products designed and manufactured by Sorin Group. Perceval is a surgical aortic valve with a unique self-anchoring frame that enables the surgeon to replace the native diseased valve without suturing it into place. Perceval is now implanted in over 10,000 patients in over 300 centers, in 34 countries across the world. The Perceval valve is currently under review by the U.S. Food and Drug Administration.

Reference
¹ Shrestha M, Fischlein T, Meuris B, et al. European multicentre experience with the sutureless Perceval valve: clinical and haemodynamic outcomes up to 5 years in over 700 patients^† . Eur J Cardiothorac Surg. 2015: Mar 6: 1-8.

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 3,900 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 100 countries.

For more information, please visit www.sorin.com

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Gabriele Mazzoletti, Tel: +39 02 69969785
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Director, Corporate Communications
Sorin Group
e-mail: corporate.communications@sorin.com
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Director, Investor Relations
Sorin Group
e-mail: investor.relations@sorin.com

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