Thoratec Corporation (Nasdaq: THOR) and Levitronix LLC have recently announced that they have signed a co- distribution agreement under which Thoratec will distribute the Levitronix CentriMag® Blood Pumping System in the United States.

Currently having USFDA 510(k) approval in the United States for use in patients requiring short-term extracorporeal (i.e. outside the body) circulatory support during cardiac surgery, the Levitronix device has a CE Mark approval and is commercially available throughout Europe to support patients in severe, potentially reversible ventricular failure for up to 14 days.

The Levitronix device has recently completed three successful pilot trials in the U.S. which demonstrated safety in patients suffering from cardiogenic shock experienced after cardiac surgery or acute myocardial infraction (AMI), and for patients requiring short term right ventricular support.

An IDE (Investigational Device Exemption) is under discussion with the USFDA for the commencement of a pivotal trial later this year to demonstrate safety and effectiveness of the CentriMag® for any cardiac condition resulting in ventricular failure where there is an opportunity for recovery, including but not limited to: AMI, post-cardiotomy cardiogenic shock, acute myocarditis, intractable ventricular arrhythmias, failed transplant and postpartum cardiomyopathy.

Levitronix has estimated the market opportunity for these indications to be $40 - $100 million. The above agreement with Thoratec Corporation is not expected to represent a meaningful contribution to revenues for the balance of 2006.

Gary F. Burbach, president and chief executive officer of Thoratec, said the following:

"We are delighted to be expanding our relationship with Levitronix, our development partner for the HeartMate(R) III centrifugal, continuous flow pump.

The Levitronix device is exciting, state-of-the art, recovery and bridge to decision technology utilizing the same magnetically levitated, contact-free technology used in our HeartMate III.

This agreement complements and broadens our offerings of circulatory support devices and leverages the strong presence of our sales force in the market."

Read the full press release.

[Photo Credit: Levitronix LLC]