Abiomed gets approval to begin trial

Heart device maker Abiomed Inc. of Danvers said today that it received conditional approval from the Food and Drug Administration to begin a clinical trial for its Impella 5.0 circulatory support system.

The "conditional" aspect of the approval means the FDA asked the company to answer a few minor questions on the study, but that does not prevent Abiomed from starting the study immediately. However, the company said it still must get the investigational review boards at the seven trial sites to sign off on starting the trials.

Abiomed plans to begin enrolling up to 20 patients in the pilot study as soon as possible. The Impella consists of catheters that can take strain off the heart by assisting with blood flow. The study will enroll patients who have been weaned off heart-lung machines after heart surgery.

The device is already approved for sale in Europe and has treated more than 250 patients, the company said.

Abiomed shares added 27 cents, or 2.2 percent, to $12.51 in morning trading on the Nasdaq. The stock has ranged between $7.81 and $14.14 over the past year. (AP)