Healthcare Industry News:  cardiopulmonary 

Devices Cardiology

 News Release - June 24, 2009

Sorin Group Announces European Market Release and First Implant of Its New-Generation Dual Chamber Implantable Cardioverter Defibrillator

New PARADYM(TM) DR ICD provides extra safety margin for patients with high defibrillation thresholds.

PARIS--(HSMN NewsFeed)--Sorin Group, (MIL:SRN) (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the commercial market release and first implant of its new generation PARADYM(TM) DR 8550 dual chamber implantable cardioverter-defibrillator (ICD).

PARADYM DR is the second product of a brand new platform with cutting-edge electrical performance, combining high energy shocks, with an expected 9.5 years longevity1 in a 32.8 cc small device.

PARADYM can charge up to 42 J, and delivers the highest energy shocks on the market whenever needed to treat a life-threatening arrhythmia.

To avoid a decrease in the patient’s quality of life, it is crucial that life-saving therapies are delivered only when necessary. PARADYM DR features PARAD®+ detection algorithm providing accurate therapy based on superior specificity in discriminating supraventricular tachyarrhythmias (SVT).

Ventricular arrhythmias often occur as regular ventricular tachycardia (VT). In most cases these VTs can be terminated by painless anti-tachy pacing (ATP), and a painful and stressful shock can be avoided. PARADYM DR is designed to detect and treat the VTs with ATP over a range of heart rates from 100 min-1 up to 255 min-1

Dr. Peter-Paul Delnoy, from the Isala Clinics in Zwolle, the Netherlands, who implanted the first PARADYM DR in a 60 year old man, commented: “Providing therapy options to my patients is of great importance. With PARADYM, its 4 tachycardia detection zones and associated therapies, I can provide a customized treatment to each patient. I also especially value the superior SVT discrimination of PARAD+, which gives me the capability to treat slow ventricular tachycardias.”

PARADYM DR also includes the SafeR(TM) function which allows spontaneous atrio-ventricular conduction, while managing all three types of heart block (first, second and third degree). In this way right ventricular pacing, which has been shown to increase the risk of congestive heart failure and atrial fibrillation, can be reduced to 0.1%2.

A lot of patients receiving an ICD suffer from Heart Failure (HF). PARADYM DR incorporates PhD(TM), a new continuous monitoring function, that measures the patient’s activity and breathing patterns, thus giving physicians additional insight into the patient’s clinical status.

Stefano Di Lullo, President of the Sorin Group CRM business unit, commented: “Sorin Group is pleased to announce the European launch of PARADYM DR. With PARADYM DR, patients can go about their daily activities, with the reassurance that arrhythmias will be accurately identified and correctly treated. PARADYM’s new PhD monitoring function is specially designed to optimize patient management. The introduction of PhD is consistent with our objective to become the innovative leader in the hemodynamic management of heart failure.”

About the 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 3,500 employees worldwide, the Group focuses on three major therapeutic areas that include: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management, and heart valve repair and replacement. Every year, over 1 million patients are treated with the devices of Sorin Group in more than 80 countries.

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

1. Pacing in DDD mode, 1% in atrium, 15% in ventricle, 500 ohm, 3.5 V, 0.35 ms, 60 min-1, one 42 J shock per quarter, sensors OFF

2. In 80% of non-selected patients, Anselme et al. Heart Rhythm 2006; 2, supp 5; p4-99


Source: Sorin Group

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