Sorin Group Announces European Market Release And First Implant Of New-Generation Cardiac Resynchronization Therapy Defibrillator

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 28 Nov 2008 - 1:00 PDT

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Sorin Group, (MIL:SRN), a global company and a leader in the treatment of cardiovascular diseases, announced today the commercial market release and first implant of its new-generation PARADYM™ CRT 8750 cardiac resynchronization therapy defibrillator (CRT-D). Together with the new SITUS™ BW 28D left ventricle pacing lead and lead delivery system, PARADYM CRT forms a complete new CRT system for heart failure (HF) patients.

PARADYM CRT is designed to allow more flexibility in the management of cardiac resynchronization and anti-tachyarrhythmia therapy in heart failure patients, thanks to the unique Brady-Tachy Overlap™ (BTO) feature.

The guidelines for heart failure management recommend exercise training as part of the treatment for HF patients, as it has been shown to reduce mortality and improve quality of life.

With BTO, PARADYM CRT is able to provide bi-ventricular resynchronization therapy at the elevated heart rates necessary to support patients' exercise. However heart failure patients often present slow ventricular tachyarrhythmias (slow VT) at the same elevated rates. Slow VTs have been reported to cause significant clinical effects. It is therefore important to detect and treat these arrhythmias.

Unlike most other CRT-D devices, PARADYM CRT is designed to recognize and treat these slow VTs without compromise to resynchronization therapy.

"The physical activity of the patient is definitely a key component to take into consideration when treating every heart failure patient. PARADYM CRT offers my heart failure patients the significant benefit of delivering resynchronization therapy during sustained exercise, while detecting and treating slower ventricular tachycardias without programming constraints," said Dr. Christian Butter, Head of Cardiology Department, Heart Center Brandenburg in Bernau bei Berlin, Germany, who implanted the first PARADYM CRT device in a 38-year-old woman. "In addition, I'm particularly satisfied with the small volume and thickness of this device."

For heart failure patients, it is crucial that life-saving therapies are delivered only when necessary, to avoid a decrease in the patient's quality of life. PARADYM CRT features PARAD®+ detection algorithm, whose superior specificity in discriminating ventricular arrhythmias has been clinically proven. Studies have demonstrated that the absolute risk of experiencing an inappropriate shock has been observed to be only 5%, the lowest percentage reported thus far. Whenever a shock is needed, PARADYM delivers it swiftly with an energy level of up to 37J (42 J stored), the highest available in the market. This will give maximum assurance to both patients and clinicians in the treatment of life-threatening arrhythmias.

Fred Hrkac, Sorin Group, President of the CRM business unit, commented: "Sorin Group is delighted to announce the launch of PARADYM CRT. The device provides patients the highest delivered energy available on the market to date in a 34 cc small and long-lasting device. With PARADYM CRT, patients have the opportunity to exercise, while arrhythmias at all different rates can be accurately treated. PARADYM CRT is the first device of a novel Sorin Group platform which will bring a wide range of treatment options for physicians and patients, further strengthening our innovative leadership in the hemodynamic management of heart failure."

About heart failure and resynchronization therapy

According to the European Society of Cardiology (ESC) and the American Heart Association (AHA), more than 10 million Europeans and 5 million Americans suffer from heart failure, the most costly cardiovascular disease.

Cardiac resynchronization therapy defibrillators are indicated in advanced heart failure patients who might be at risk for Sudden Cardiac Death (SCD). CRT-D devices are capable of resynchronizing the contractions of the ventricles (the heart's lower chambers) by delivering low-energy impulses to improve the pumping performance of the heart. They also provide patients with defibrillation support when abnormally fast, life-threatening heart rhythms occur.

About the Sorin Group

The Sorin Group, a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm dysfunctions, interventional cardiology, and the treatment of chronic kidney diseases. At the Sorin Group, more than 4,000 employees work to serve over 5,000 public and private treatment centers. Every year, over 1 million patients are treated with the devices of Sorin Group in more than 80 countries.

Sorin Group

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