Medical Device Daily

Abiomed (Danvers, Massachusetts), a company best known for it's artificial heart, has received approval from the FDA for its iPulse Circulatory Support System, a combination console and disposable balloon which drives Abiomed and other manufacturer's intra-aortic balloons (IAB), Abiomed's BVS 5000 and the AB5000 ventricular assist devices (VAD), and the similar technologies of other manufacturers.

In response to Abiomed's pre-market application supplement (PMA-S), the FDA has granted permission to distribute the device for use with patients suffering from acute heart failure.

"What's unique about this product is that iPulse is the only one that does it all. It can be used to provide total circulatory support or for counter-pulsation therapy," Michael Minogue, president/CEO of Abiomed, told Medical Device Daily. "It's more cost effective and already has four DRGs [diagnostic related groups] from $20,000 to $250,000."

The mechanical circulatory system, which will be priced at $95,000, will help Abiomed to further penetrate markets such as transplant centers and hospitals that do open heart surgeries.

Abiomed's AB5000 is currently installed at about 50% of the U.S. transplant hospitals and 23% of the U.S. open heart hospitals, Minogue said, adding that Abiomed has not yet produced a sales forecast for iPulse.

Minogue said rollout of the iPulse is expected to begin during the first quarter of 2008.

The company should have no problem financing the commercialization effort. "Our status at the end of last quarter was that we had $60 million in cash and no debt," he said.

Abiomed has diversified in recent years after the launch of AbioCor, an artificial heart, in an effort to develop products that help ailing hearts without replacing them.

"This is an important milestone for Abiomed and an opportune time to be entering the $200 million IAB market," said Minogue. "We believe the iPulse will create new opportunities in open heart hospitals and help fuel growth in our AB5000 disposables."

There are an estimated 160,000 IAB's used globally each year with about 110,000 annual U.S. procedures. More than 1,000 open heart hospitals, which include around 100 transplant hospitals, could potentially use an IAB as their initial level of circulatory support in the U.S.

Abiomed originally estimated a summer 2007 launch of iPulse in the U.S. Minogue said a lengthy FDA review delayed the launch.

Abiomed reported the first treatment of a patient in Europe with its IAB and iPulse console under its recent CE-mark approval.

J.P.S. Henriques, MD, a cardiologist at Academic Medical Center (Amsterdam, the Netherlands), used the intra-aortic balloon pump during an angioplasty procedure.

"We had a positive experience with the iPulse Console and Abiomed's intra-aortic balloon, finding the technology to be safe and easy to use. This new intra-aortic balloon is a good front-line treatment option to provide patients with minimally invasive cardiac perfusion," said Henriques.

The procedure, which lasted about an hour, provided increased circulation during angioplasty to an 84-year-old patient requiring stents to the left main artery, the vessel that supplies blood to the heart.

In an effort to access a broader customer base, Abiomed said recently it would loan $5 million in convertible secured debt to WorldHeart (Oakland, California), with a term of two years and bearing interest at 8% per annum, as part of a strategic investment in the company.

Overall, development and commercialization of the iPulse and similar products, have dominated the company's efforts over the past several months, thus providing support technologies for patients' native hearts, rather than the company's previous strong emphasis on the AbioCor artificial heart.

Since its initial in-human trial of the AbioCor, the company has not proceeded with additional implants, with one explanation being the expectation that the company has put its energies into its development of the second-generation AbioCor before pursuing further implants.

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