Medical Device Daily Associate Managing Editor

Abiomed (Danvers, Massachusetts) reported the FDA clearance of its new intra-aortic balloon (IAB); an easy-to-insert, minimally invasive technology designed to enhance blood flow to the heart and other organs for patients with diminished heart function.

The company said the clearance by the FDA culminates more than two years of internal research and development and reflects its “expertise and core competency in advanced circulatory care technologies.”

The new balloon, the company noted, was subject to extensive reliability testing and successfully demonstrated a life of more than eight million cycles, which equates to more than 90 days of continuous operation.

In addition to the IAB, the company has developed a combination console platform, the iPulse, currently under regulatory review and pending approval, to support the new IAB. The new iPulse console will also support Abiomed’s BVS and AB5000 circulatory support systems, as well as new product introductions by Abiomed in the future. The iPulse is also designed to be compatible with other OEM’s balloons as well.

Michael Minogue, Abiomed’s president and CEO said during a conference call on the approval that the IAB “extends Abiomed’s clinical and market reach further upstream in acute patient care, including direct usage in the intensive care unit [ICU].

He added that the IAB “complements Abiomed’s products in the cardiac catheterization (cath) lab and surgical suite, allowing access to more acute patients.”

The company said this new IAB technology strengthens Abiomed’s portfolio of products, which now includes three platforms (Impella, iPulse, and AbioCor) and consists globally of seven disposable devices that span the cath lab to the intensive care unit to the surgery suite.

According to Minouge, there are an estimated 1.1 million acute heart failure patients annually in the U.S. alone, with such conditions as acute myocardial infarction (AMI or heart attack), cardiogenic shock, myocarditis, postcardiotomy cardiogenic shock, or patients needing support for high-risk cardiac procedures.

Abiomed’s 8 French IAB is inserted percutaneously into a patient’s descending aorta and inflates and deflates in counterpulsation to a patient’s heart rhythm.

“Abiomed has a clear opportunity to enter the IAB space as the only company that can provide a continuum of treatment options for patients in acute heart failure whether they need minimal, moderate, or full bi-ventricular support with upwards of six liters of pulsatile flow,” said Minogue

The new iPulse console will now support procedures with associated Medicare reimbursement that extends across four diagnostic related groups (DRGs 110, 111, 525, 103) ranging from $15,000 to $180,000 per patient stay. The return on capital investment for the iPulse console can be achieved in less than six months, the company said.

According to Minouge, these approvals give the company into a new and growing market. He estimated that the IAB market has an estimated 100,000 patients annually in the U.S. and about 160,000 patients worldwide. He said the global balloon market is about 200 million. “Approximately 70% of the annual market opportunity is derived from disposable balloons, which represents a clear and immediate opportunity for Abiomed’s IAB,” said Minouge.

“We believe this IAB offering and integrated iPulse console provide an opportunity to accelerate our revenue growth as we launch these products in the global markets. We also expect the technology to fuel demand for our AB5000 consoles and ventricles as we leverage our installed base in the surgical suite, where roughly one third of intra-aortic balloons are inserted,” said Minogue. He added that Abiomed “plans to enter this $200 million additional market consisting of 160,000 patients with a combination of our IAB, Impella and AB5000 technologies to achieve the best recovery outcomes. Abiomed has the most extensive portfolio of circulatory care technologies in the industry and a strong platform for new product introductions.”

Abiomed said it expects to begin shipping its integrated iPulse console outside the U.S. during fiscal fourth quarter ending March 31, 2007. Following FDA approval of the pre-market application (PMA) supplement to the existing console, Abiomed’s initial introduction of the new iPulse is expected in the summer of 2007 to leading heart hospitals.