Abiomed (Danvers, Massachusetts) has received 510(k) clearance from the FDA for its Impella 2.5 cardiac assist device, a new kind of tool for the cath lab that interventionalists can use to increase blood flow to the heart muscle and vital organs.

The current "gold standard" for short-term cardiac support is intra-aortic balloon pumping (IABP), with about 110,000 cases per year in the U.S. using this technology.

Abiomed reported late last year that it had received FDA approval for its own IABP system, the iPulse, in 2006 (Medical Device Daily, Dec. 21, 2007).

"FDA clearance of the Abiomed Impella 2.5 represents the next step in enabling heart recovery for patients in the U.S. and will likely change the standard of care in the catheterization lab," said Michael Minogue, president/CEO of Abiomed. "The device seamlessly provides immediate, minimally invasive circulatory support for critical patients."

This 510(k) clearance allows Abiomed to begin selling the device to the estimated 14,000 interventional cardiologists at roughly 1,700 heart hospitals in the U.S.

"Commercial launch starts today," Minogue said in a conference call to investors. "We will target the top 300 of 1,700 heart hospitals. We have enough supply to meet FY09 sales forecast because of a significant investment we made last year in our German manufacturing facility."

He added that the company is preparing another manufacturing facility with 10 times the capacity of the company's Aachen, Germany, facility.

Abiomed is charging $50,000 for a console needed to run the pumps and $20,000 for each disposable unit. "This price point is affordable for hospitals because CMS reimbursement is already in place," Minogue said.

The Impella 2.5 is inserted percutaneously in the cath lab via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. Impella is cleared for use under the 510(k) for partial circulatory support for periods up to six hours.

The Impella is approved in more than 40 countries, including for up to seven days of support under the CE-mark in Europe.

Abiomed also is currently conducting two U.S. pivotal studies comparing the Impella to the IABP. In March, the company received conditional FDA approval to begin a study under an investigational device exemption for hemodynamically unstable patients undergoing a percutaneous coronary intervention (PCI) procedure due to acute myocardial infarction (AMI), commonly referred to as heart attack.

The AMI shock study will determine the safety and effectiveness of Impella as a left ventricular assist device for heart attack patients as compared to optimal medical management with an IABP.

The randomized study, at up to 150 hospitals, is comprised of two arms: those patients that receive the Impella for up to five days as a left ventricular assist device and patients that receive IABP therapy.

The study will compare 192 Impella patients to 192 IABP patients relative to a composite end point comparing safety and efficacy. The primary endpoint will be a composite endpoint of major events assessed at 30 days post-PCI.

Following Institutional Review Board approval at each participating hospital and requisite training, the company plans to ship Impella disposables and consoles to enrolled sites.

It is estimated that there are more than 100,000 AMI anterior infarct patients annually in the U.S. These patients suffer failure of the left ventricle, the large main pumping muscle of the heart. Feasibility studies show that of heart attack patients, these are the patients that can be most helped by the Impella.

For Abiomed, this translates to a potential market opportunity to the tune of more than $2 billion in yearly revenue for this indication alone.

There are an estimated 60,000 annual high-risk PCI patients in the U.S., representing a potential addressable U.S. market in excess of $1 billion.