Terumo Heart, Inc. Submits IDE to FDA for U.S. Destination Therapy Trial for the DuraHeart(TM) Left Ventricular Assist System

ANN ARBOR, Mich., April 14 /PRNewswire-FirstCall/ -- Terumo Heart Inc., a wholly owned subsidiary of Terumo Corporation, today announced the submission of its Destination Therapy (DT) Investigational Device Exemption (IDE) to the FDA for its DuraHeart™ Left-Ventricular Assist System (LVAS).  This is a first step in the process of obtaining approval to begin its DuraHeart DT Clinical Trial in the U.S. The IDE submission follows the company's recent FDA notification granting unconditional status on the U.S. DuraHeart Bridge-to-Transplant (BTT) clinical trial, which is currently enrolling patients.  

Destination therapy provides long-term mechanical circulatory support for patients suffering from advanced-stage heart failure who are not eligible for heart transplantation. It is estimated that there are more than 100,000 patients annually who may benefit from this therapy.

"Our destination therapy submission represents an important advance in our DuraHeart clinical program, one based on our confidence in its clinical benefit and with the ongoing support of Terumo Corporation," said William Pinon, President and CEO of Terumo Heart.  "There is a significant need and opportunity to serve advanced-stage heart failure patients who are not eligible for transplant.  With our recent FDA notification of unconditional approval status for our DuraHeart BTT trial, we anticipate further expansion of our clinical sites and acceleration of patient enrollment."

The DuraHeart LVAS is the latest-generation rotary blood pump designed for long-term patient support.  The system incorporates a centrifugal flow rotary pump with an active magnetically levitated impeller featuring three position sensors and magnetic coils that optimize blood flow. The impeller's magnetic levitation is designed to eliminate friction by allowing a wide gap between blood contacting surface areas, enabling blood to flow through the pump unimpeded in a smooth non-turbulent fashion.

The DuraHeart LVAS is currently being studied in the DuraHeart Pivotal U.S. Trial for Bridge-to-Transplant, a multi-center, prospective, non-randomized study, involving 140 patients.  The study will evaluate the safety and efficacy of the device in helping to sustain patients awaiting heart transplant who are at risk of death due to end-stage heart failure.  The DuraHeart LVAS carries a CE Mark and is currently available for sale in European countries.  Additionally, the company has completed clinical trial enrollment for this device in Japan.

For more detailed information about the DuraHeart BTT Trial, visit www.clinicaltrials.gov and for more information about the DuraHeart LVAS, visit www.terumoheart.com.

About Heart Failure

More than 22 million people suffer from heart failure worldwide with approximately one million new patients diagnosed annually. In the setting of an aging global population, heart failure is the number one reason for hospitalization.  The most severely ill patients need heart transplants in order to recover. More than 8,000 people worldwide are on the list of eligible candidates for heart transplants annually, but less than 3,000 will receive a transplant each year.  A large number of people who suffer from severe heart failure do not qualify for transplantation due to other health issues. An alternative for these patients is access to artificial mechanical assist devices.  Left Ventricular Assist Systems are a type of mechanical circulatory device specifically designed to improve the quality of life of the patients waiting for donor hearts, as well as those who are ineligible for a heart transplant.

About Terumo Heart, Inc.

Terumo Heart, Inc. is a U.S. subsidiary of Terumo Corporation with headquarters and manufacturing facilities in Ann Arbor, Michigan.  The company's focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients.  Terumo Corporation, located in Tokyo, Japan, is a leading developer, manufacturer and global marketer of a wide array of medical products. DuraHeart is limited to investigational use only in the United States, and is CE marked in Europe.  For more information visit www.terumoheart.com.

SOURCE Terumo Heart, Inc.