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Medtronic wins FDA nod, CE mark for angioplasty balloon

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Medtronic won FDA clearance for the Pacific Plus balloon catheter.--Courtesy of Medtronic

Medtronic ($MDT) is expanding its presence in peripheral artery disease, winning FDA clearance and a CE mark for the Pacific Plus balloon catheter, a next-generation vascular treatment.

Pacific Plus is a percutaneous transluminal angioplasty catheter designed to treat narrowed arteries around the body, and Medtronic touts the device as easier to use and faster to inflate than its competitors, making for a shorter procedure time. The device follows Medtronic's Pacific Xtreme catheter, already available around the world.

The company bills Pacific Plus as ideal for a wealth of peripheral arteries, including the renal, iliac, iliofemoral, femoral, popliteal and infrapopliteal. Juan Pablo Zambrano, director of cardiovascular medicine at Jackson South Community Hospital in Miami, said in a statement that vascular specialists have been waiting for a device versatile enough to handle simple and complex procedures.

Medtronic has been working to grow its endovascular business over the past year, unveiling new products and indications to dull the effects of softening markets in spinal and cardiac rhythm devices. The launch of Pacific Plus coupled with the recent FDA approval of Medtronic's Endurant II Aorto-Uni-Iliac stent graft will help the company drive sales for its endovascular offerings, all while it works toward FDA approval for the IN.PACT Admiral drug-eluting balloon, which it hopes to launch in 2015.

Last quarter, Medtronic's endovascular business grew 7% to $235 million, sped along by strong sales of the Valiant Captivia stent graft in the U.S., China and Japan.

- read the announcement

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