Abiomed (Danvers, Massachusetts) rang in year 2008 by issuing an update to its European strategy to drive growth by establishing the concept of recovery as the goal for patients experiencing acute cardiac events.

Acute myocardial infarction (AMI) results in more than 200,000 deaths a year in Germany, France, the UK, Spain, Italy and Russia, the company notes. To deal with these sad numbers Abiomed is developing its portfolio of circulatory care products, including the iPulse and the AB5000, approved in 27 European countries, with the Impella now approved in more than 40 countries outside the U.S.

While the company’s AbioCor artificial heart remains the company’s flagship product in some minds – and the AbioCor receives positive ink in a new special issue of Scientific American, “BODY” — the company has clearly emphasized the expansion of its heart support systems over the past several months, rather than pursuing further implants of the AbioCor under the Humanitarian Device Exemption approval granted by the FDA in 2006 (Medical Device Daily, Sept. 7, 2006).

Abiomed said it has continued to invest in its sales, clinical, marketing and field service teams in Europe to promote recovery for acute heart failure patients and boost revenue growth. Revenue in Europe for the first two quarters of Abiomed’s FY08 represented the highest six-month revenue total for the region in Abiomed’s history, the company said. And it reports that the Impella technology has been the subject of more than 40 publications.

“We are pleased with our European revenue growth and progress in major initiatives such as expansion of distribution resources and company offices into major European Union markets, improved reimbursement for hospitals, positive clinical studies, and continued investment in our German manufacturing capabilities to prepare for future growth in the U.S.,” said Michael Minogue, president/CEO and chairman of Abiomed.

“We are increasing our distribution network to drive continued penetration and growth in the European markets,” said Paul Krell, VP and general manager of Abiomed Europe Operations. “The favorable patient experiences and positive clinical data are fueling European interest in the Impella and iPulse platforms, and we are pleased that reimbursement is now established in Germany and Italy.”

Aachen, Germany, is headquarters for Abiomed’s European operations where all Impella products are made. Additionally, the company has formed subsidiaries and has appointed country managers in France and the UK.

The company reports that more than 50 patients have already been treated in France with its technologies since the opening of its office there. The company opened its office in the UK in November and has reported that the first patient was recently treated with the Impella 2.5 system.

“The Impella 2.5 provided effective support during a high-risk PCI procedure for the patient who had low ejection fraction,” said Farzin Fath-Ordoubadi, MD, of the Manchester Royal Infirmary (Manchester, UK). “The clinical outcome was favorable, and we believe that Impella improved the safety of this procedure.”

Abiomed’s Impella 2.5 and 5.0 catheters are percutaneous micro heart pumps with integrated motors and sensors for use in interventional cardiology and heart surgery. The devices are designed for use by interventional cardiologists to support pre-shock patients in the cath lab who may not require as much support as patients in the surgery suite. Impella catheters are also designed to provide ventricular support for patients requiring hemodynamic stabilization or suffering from reduced cardiac output, and can aid in recovering the hearts of patients following a heart attack.

These products increase flow to the heart and organs without the need for drugs such as inotropes while reducing the workload of the heart. FDA has not yet approved the Impella products are for sale. The company reports Impella technologies now installed at EU centers in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Netherlands, Spain and the UK, the company said.

In August the company reported getting conditional FDA approval to begin its clinical trial in the U.S. for the Impella 2.5 (MDD, Aug. 31, 2007).

Then, in October, the company received a written response from the agency outlining four areas of concern for which they wanted more information related to its submission for 510(k) clearance of the Impella 2.5. Two of the questions requested clarification and additional information related to labeling within the 510(k) submission. A third question requested more information related to bench-testing of the device. A fourth question requested that Abiomed provide an updated clinical review of the global experience with the Impella 2.5 since the original 510(k) submission, including up to date information from the U.S. safety pilot clinical trial for the device.

Minogue said at the time that the company would “continue to work diligently” with the agency to provide the requested information. He said the company remained confident that it was still on a 510(k) path with a potential clearance sometime between November and March (MDD, Oct. 12, 2007).

The iPulse Circulatory Support System is designed to treat patients suffering from acute heart failure by offering various levels of cardiac support, whether minimal, moderate, or full bi-ventricular, to potentially recover the patient’s native heart. The iPulse combination console drives Abiomed and other manufacturers intra-aortic balloons (IAB), Abiomed’s BVS 5000 and AB5000 Ventricular Assist Devices (VAD), as well as new products Abiomed may offer in the future.

According to the company, the iPulse is the first console with the capability to provide either VAD or IAB support in the catheterization lab and surgery suite. Abiomed reported FDA approval for the iPulse last month (MDD, Dec. 21, 2007).

The AB5000 Circulatory Support System provides temporary support of acute heart patients in profound shock, including patients suffering from cardiogenic shock after a heart attack, post-cardiotomy cardiogenic shock, or myocarditis. The AB5000 VADs are surgery suite products and can assume the full pumping function of a patient’s failing heart, allowing the heart to rest, heal and potentially recover.

AB5000 is designed to provide either univentricular or biventricular support.