Contego’s PAD angioplasty balloon earns CE mark

Blood
Contego's device combines an angioplasty balloon and embolic filter in one catheter, eliminating the need for additional devices to protect patients from embolism.

Contego Medical picked up a CE mark for its angioplasty balloon system for the treatment of peripheral artery disease.

Characterized by narrowed blood vessels that restrict blood flow to the limbs, peripheral artery disease affects as many as 9 million people in the U.S. While it has a relatively low risk of death, affected limbs have a higher risk of infection and advanced cases could require amputation.

Raleigh, NC-based Contego’s Vanguard IEP Peripheral Balloon Angioplasty System incorporates embolic protection—the device combines an angioplasty balloon and an embolic filter on the same catheter, the company said in a statement. Used in lower limb angioplasty, it protects the legs from blood clots and other debris that may block the blood vessels without needing additional devices.

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Related: FDA green-lights Gore's self-expanding stent for peripheral artery disease

"The Vanguard IEP System is an important step toward enhancing safety for patients undergoing peripheral angioplasty for occlusive disease," said Thomas Zeller, director of the Department of Angiology at Universitaets-Herzzentrum Freiburg in Germany and principal investigator of an upcoming clinical study of the device.

The device “will be of particular importance” for patients with a high risk of embolism—or a blockage in the arteries—such as those with acute limb ischemia or chronic total occlusions. It will also be useful in patients with diabetes who are at higher risk of needing amputation if they do suffer an embolism.

Shockwave Medical markets an angioplasty balloon that combines traditional techniques with lithotripsy, or ultrasound shock waves, to treat peripheral artery disease. The device delivers intermittent shock wave pulses to break up hardened calcium in the arteries, while an angioplasty balloon restores blood flow.

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