A new type of mechanical support for heart failure patients signals the wave of the future for heart technology. Not only has it opened the therapeutic door for the sickest women and smaller men, but it's a whole new paradigm for this type of device.

With yesterday's news that Thoratec's (Pleasanton, California) HeartMate II Left Ventricular Assist System (LVAS) was FDA-approved (Medical Device Daily, April 21, 2008), several milestones were achieved.

"This is the very first of its kind LVAS and is very significant — it's where this type of mechanical heart technology is going now," FDA spokeswoman Karen Riley told MDD.

Previous pumps were pulsatile, stimulating action of the heart. HeartMate II uses a continuous flow pump that constantly moves blood with a single moving part, a spinning rotor. And that's what allows the device to be smaller. Because there's only one moving part, there's less potential for breakage, Riley pointed out.

Thoratec is riding the wave, working quickly to roll out HeartMate for that indication while continuing the same study, seeking approval for a second, even broader population.

Monday's approval is specifically intended to be used as a temporary fix for patients awaiting transplantation. Noted as the Bridge-to-Transplantation (BTT) indication, it's for New York Heart Association Class IV patients. What's exceptionally unique about HeartMate is that it has been downsized for use in women and smaller men, and that it is more durable, lasting up to 10 years.

"Typical patients who come to mind are those who need some sort of support as a BTT," Thoratec's David Smith, executive VP and CFO, told MDD. "Not just women, but men who are smaller. In the past, certainly smaller body sizes have been underserved. Predecessor devices have been too large. We're pleased the label allows the physician to make the determination on which device and size to use."

Now, Thoratec forges ahead with part two of the same study, for patients who were not candidates for cardiac transplantation and meet specific inclusion and exclusion criteria. It's the first time the FDA has approved a clinical trial with both indications in one protocol.

Dubbed the Destination Therapy (DT) study, the criteria of this second-part, 479-patient trial includes patients who are not yet as ill as those in the company's original REMATCH trial (MDD, June 8, 2005), and allows for inclusion of some late New York Heart Association Class IIIB heart failure patients.

"Destination therapy would be for those patients who are not transplant-eligible," Smith said. "This is a larger patient population. One of our devices is currently approved for this indication [Heartmate XVE]. But it hasn't seen much uptake because of durability of the device, which is 18 to 24 months. We believe HeartMate II has much greater durability ... out to 10 years."

Between 2,000 and 2,500 Americans receive a heart transplant each year, while another 25,000 to 50,000 die waiting for a donor heart to become available. Upwards of 5 million Americans suffer from heart failure.

The primary outcome measure for the 439-patient HeartMate II BTT trial was the rate of survival to transplantation or 180 days. The primary endpoint of the HeartMate II DT trial will be two years, which includes patient survival, rate of neurological events and device reliability.

With a price tag of $80,000, Smith said HeartMate is covered for virtually all payers, public or private. For Medicare, implantation of VADs has been covered since the late-1990s under a National Coverage Determination for VADs used as BTT.

"CMS over last couple of years has recognized the value of mechanical support and ventricular devices in particular," Smith said. "Last October, the DRGs that would be associated went up 25%. So that was a strong endorsement for these types of devices."

He said roll-out of HeartMate will begin immediately. "We have pumps on the shelf and we are working to get the labels printed. We've been supplying these throughout the clinical trail and have the stock ready to ship."

The HeartMate II is an axial flow device that can pump up to 10 liters of blood per minute, the full output of a healthy heart. It is implanted alongside a patient's native heart and takes over the pumping ability of the weakened heart's left ventricle.

Thoratec is financially prepared to deliver product and forge ahead with the broader indication.

"We are excellent financial shape," Smith said. "At the end of 2007, we had $218 million in cash. We're profitable and we're not looking for any additional funding."