Shockwave Medical Gets FDA Clearance and CE Mark for Catheter

Shockwave Medical has received the FDA’s 510(k) clearance and a CE mark for its Shockwave M5+ peripheral intravascular lithotripsy (IVL) catheter.

The catheter is designed to treat otherwise difficult-to-treat calcified lesions in the peripheral arterial system of the lower extremities. The shockwave treatment can reduce treatment time and expand therapy to patients with larger vessel sizes, the Santa Clara, Calif.-based company said.

The peripheral catheter can be an effective option for “some of our most difficult-to-treat patients, some of whom previously could not have been treated with IVL,” said Peter Soukas, of Miriam and Rhode Island Hospitals, Providence, R.I., who was one of the first physicians to use the new device.