Less than 2 weeks after touting first-in-man use of its catheter-based Impella cVAD heart pump, Abiomed (NSDQ:ABMD) won CE Mark approval to launch the device in the European Union.
EuroZone regulators cleared the device for up to 5 days of pumping support for patients with a number of heart conditions, as well as for support during coronary bypass surgery or during or after percutaneous coronary intervention.
The news got a modest response from Wall Street today, where ABMD shares were up 0.6% to $21.03 as of about 12:10 p.m.
Abiomed unveiled the Impella cVAD device, the latest in its star Impella line of devices, in December 2011.
The new Impella cVAD device is a "paradigm shift," according to Abiomed CTO Thorsten Siess. Unlike other VADs that are surgically implanted, the Abiomed product is inserted via catheter.
"We know that the cath lab may require, in certain cases, prolonged, profound support beyond what we can offer today," Siess said.
The Danvers, Mass.-based med-tech pioneer plans to fully launch the Impella cVAD in European markets by this summer, according to a press release.
Abiomed also has plans for the Land of the Rising Sun, where the Impella has been listed as a "critical need" device by major cardiac societies. Because there is virtually no use of heart transplants or VAD devices in Japan, a device like the Impella has an extra leg up there, according to the company.
It’ll have company in the cardiac assist device market soon, as Pleasanton, Calif.-based VAD leader Thoratec (NSDQ:THOR) prepares its version of a percutaneous heart pump to compete with Impella. Thoratec hopes to win Japanese regulatory approval for its workhorse HeartMate II ventricular assist device in mid-2012, CEO Gary Burbach said at the JP Morgan health care conference in San Francisco earlier this year.
