Healthcare Industry News:  cardiac resynchronization therapy 

Devices Cardiology FDA

 News Release - May 6, 2009

FDA Approves New Medtronic Left Heart Lead for Cardiac Resynchronization Therapy Devices

First Use of NASA Technology in This Kind of Implantable Medical Device

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE: MDT ) today announced U.S. Food and Drug Administration (FDA) approval and availability of the Attain Ability(R) left-heart lead (Model 4196) for use with cardiac resynchronization therapy (CRT) devices for heart failure patients. Attain Ability has the thinnest lead body of any left-heart lead currently available, providing physicians with a tool to deliver therapy directly to hard-to-reach areas of the heart. Attain Ability incorporates insulation material developed by NASA Langley Research Center that was previously evaluated for space applications, high-performance engines and harsh environments. This application marks the first time a NASA-developed material has been used in this kind of implantable medical device.

“Attain Ability is the latest innovation in our long-term strategy to provide physicians with a broad portfolio of leads and delivery systems to meet the unique needs of their patients,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “We’re proud to partner with NASA, another innovation leader, to provide physicians with a unique, technology-based solution to assist physicians with optimal lead placement in heart failure patients.”

Navigating a lead through the intricate curves of the heart’s anatomy to place the lead in the ideal location on the left ventricle is recognized by physicians as the most challenging aspect of implanting CRT devices. The compact, flexible design afforded by the NASA insulation material makes this the thinnest left-heart lead body on the market. Its design allows physicians to choose between different sites in order to deliver optimal therapy. Additionally, Attain Ability can be delivered by an inner catheter, the Attain Select(R) II. This feature helps physicians place the lead directly in difficult-to-reach areas of the heart. A clinical study involving 190 patients at 25 centers in the United States and Canada showed physicians were successful in placing the Attain Ability lead 96.4% of the time.

“The unique design of the Attain Ability lead provides clinicians with a greater degree of flexibility in left ventricular lead placement,” said Brian Ramza, M.D., Ph.D, director of Electrophysiology Laboratory Services at the Mid America Heart Institute, Saint Luke’s Hospital, Kansas City, Mo., and principal investigator of the Attain Ability clinical trial. “The lead provides the flexibility of multi-site pacing from small veins because of its design, therefore, truly having the potential to improve outcomes for patients with unique needs.”

In addition to the United States, the Attain Ability lead is available in Europe, Japan, Canada, and Australia. The Attain Ability lead is compatible with the Attain family of exclusive delivery tools including the Attain Select II, the Attain Hybrid(R) Guide Wires and Attain Command(TM) – the newest family of left-heart lead delivery catheters now available in the United States and Canada. As part of Medtronic’s fully integrated CRT system, the entire Attain portfolio, including the Attain StarFix(R) left-heart lead, can be used with Medtronic’s Vision 3D(TM) portfolio of wireless CRT-Ds.

About cardiac resynchronization therapy

In CRT, a stopwatch-sized device is implanted into the chest and connected by leads to the heart’s left and right ventricles. Through electrical impulses, the device resynchronizes heartbeats, allowing blood to be pumped more effectively through the body. CRT defibrillators (CRT-D) incorporate additional lifesaving therapy to quickly terminate an abnormally fast, life-threatening heart rhythm. CRT and CRT-D have become increasingly important therapeutic options for patients with moderate and severe heart failure since Medtronic first began clinical evaluation of its CRT systems in 1997.

About Heart Failure

Heart failure is a chronic and progressive condition that affects more than 5 million Americans and more than 22 million worldwide. Heart failure occurs when the heart muscle is unable to pump effectively to meet the body’s need for blood and oxygen. In the late stages of heart failure, the heart cannot keep up with the body’s demand for oxygen-rich blood and its ability to pump blood significantly deteriorates, creating a backup of blood flowing into the heart. This extra blood pools in the pulmonary veins and causes fluid to build in the lungs and other tissues. Additionally, when the heart is not pumping properly, even mild activity can cause shortness of breath or difficulty breathing. cardiac resynchronization therapy is designed to coordinate the contraction of the heart’s two lower chambers and improve the heart’s efficiency to increase blood flow to the body.

About Medtronic

Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.

Source: Medtronic

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