NEW YORK, March 24 (Reuters) - U.S. health regulators have approved next generation versions of a pair of Medtronic Inc pacemaker systems designed to help the heart work more efficiently in heart failure patients, the company said.
The Food and Drug Administration gave a green light to Medtronic's Consulta and Syncra Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Systems.
The company said on Thursday that it will begin shipping the products immediately.
The stopwatch-sized devices are implanted in the upper chest. They resynchronize contractions of the ventricles by sending tiny electrical pacing impulses to the heart muscle, helping it to pump blood throughout the body more efficiently, reduce symptoms of heart failure, such as chest pain, and help decrease deaths.
The Consulta employs a Medtronic monitoring system that identifies patients at risk for worsening heart failure before symptoms develop.
Both devices include technology that enables remote monitoring by doctors and are designed to deliver cardiac resynchronization therapy even during episodes of atrial fibrillation, or dangerously irregular heartbeats, the company said.
'Atrial arrhythmias are the number one cause of reduced cardiac resynchronization therapy. Therefore there is a real need for next-generation devices that can deliver lifesaving CRT in this patient population,' Dr. Robert Canby of the Texas Cardiac Arrhythmia and Seton Medical Center in Austin said in a statement.
'These new innovative technologies allow physicians to proactively manage their heart failure patients, and offer cutting-edge features that contribute to patient safety and physician ease-of-use,' Canby said.
Heart failure affects more than 22 million people worldwide and is a leading cause of hospitalization among people aged 65 years and older, Medtronic said.
Medtronic shares rose to $38.35 in extended trading from their New York Stock Exchange close at $38.22.
(Reporting by Bill Berkrot; Editing by Steve Orlofsky) Keywords: MEDTRONIC/APPROVALS (bill.berkrot@thomsonreuters.com; +1 646 223-6030; Reuters Messaging: bill.berkrot.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2011. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
The Food and Drug Administration gave a green light to Medtronic's Consulta and Syncra Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Systems.
The company said on Thursday that it will begin shipping the products immediately.
The stopwatch-sized devices are implanted in the upper chest. They resynchronize contractions of the ventricles by sending tiny electrical pacing impulses to the heart muscle, helping it to pump blood throughout the body more efficiently, reduce symptoms of heart failure, such as chest pain, and help decrease deaths.
The Consulta employs a Medtronic monitoring system that identifies patients at risk for worsening heart failure before symptoms develop.
Both devices include technology that enables remote monitoring by doctors and are designed to deliver cardiac resynchronization therapy even during episodes of atrial fibrillation, or dangerously irregular heartbeats, the company said.
'Atrial arrhythmias are the number one cause of reduced cardiac resynchronization therapy. Therefore there is a real need for next-generation devices that can deliver lifesaving CRT in this patient population,' Dr. Robert Canby of the Texas Cardiac Arrhythmia and Seton Medical Center in Austin said in a statement.
'These new innovative technologies allow physicians to proactively manage their heart failure patients, and offer cutting-edge features that contribute to patient safety and physician ease-of-use,' Canby said.
Heart failure affects more than 22 million people worldwide and is a leading cause of hospitalization among people aged 65 years and older, Medtronic said.
Medtronic shares rose to $38.35 in extended trading from their New York Stock Exchange close at $38.22.
(Reporting by Bill Berkrot; Editing by Steve Orlofsky) Keywords: MEDTRONIC/APPROVALS (bill.berkrot@thomsonreuters.com; +1 646 223-6030; Reuters Messaging: bill.berkrot.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2011. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
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