Benzinga | Jul 29, 2021 08:31AM EDT

Surmodics Announces Successful First Patient Use of Pounce Thrombectomy System

Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that J. Michael Bacharach, MD, vascular interventionalist/cardiologist at North Central Heart, a division of Avera Heart Hospital in Sioux Falls, South Dakota, successfully treated the first patient with the company's Pounce(tm) Thrombectomy System.

The procedure, completed last month, involved a patient presenting with increasing pain in the left leg and was diagnosed with an occluded superficial femoral artery (SFA). Three passes of the Pounce device removed 30 cm of subacute thrombus and blood flow was successfully restored. Eight additional cases have since been performed in the U.S., with positive outcomes reported following each procedure.

"Despite the challenge presented by this particular case, I couldn't have asked for anything more. The device's performance was really amazing," said Dr. Bacharach. "I was able to safely and effectively achieve a positive outcome for this patient with minimal blood loss and without the use of thrombolytics. I'm very excited about the results of this case. I'm a believer in the Pounce system!"

The Pounce Thrombectomy System, which received U.S. Food & Drug Administration (FDA) 510(k) clearance in Sept. 2020, is a mechanical thrombectomy device intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. Depending on the age and magnitude of the occlusion and the viability of the threatened limb, existing treatments for this condition may include catheter directed thrombolysis, surgical embolectomy, and/or percutaneous mechanical thrombectomy. In cases in which the occlusion has caused irreversible damage to the limb, acute limb ischemia can result in the amputation of a lower extremity.

"I am delighted that the Surmodics team is providing peripheral interventionalists with this innovative tool for treating arterial thrombotic occlusions," said Gary Ansel, MD, founder and former Chief Medical Officer of Embolitech, from which Surmodics acquired the technology and intellectual property behind the Pounce Thrombectomy System. "I also congratulate the company on its continued efforts to advance therapies for patients dealing with arterial thrombosis and peripheral arterial disease (PAD) while focusing on ease of use and efficiency for the physicians treating these patients."

"We are grateful for Dr. Bacharach and his partnership in performing this first case with the Pounce Thrombectomy System," said Gary Maharaj, President and Chief Executive Officer of Surmodics. "We are highly encouraged by his initial feedback. Having such a positive experience with this first case is a testament to this product and delivers on our timeline goal of getting our first successful case in third quarter of FY21. We look forward to the expansion of our evaluation efforts in the weeks ahead."