Penumbra receives FDA clearance for stroke thrombectomy device

Penumbra Inc. (NYSE: PEN) announced it received U.S. Food and Drug Administration clearance for THUNDERBOLT, a computer assisted vacuum thrombectomy device designed to treat acute ischemic stroke.

The device represents the first computer assisted vacuum thrombectomy platform to deliver modulated aspiration for acute ischemic stroke treatment. THUNDERBOLT uses technology designed to detect, fatigue, and remove blood clots at the site of arterial blockages.

The system will be packaged with one of Penumbra's catheters including RED 62, RED 68, RED 72 SILVER LABEL or RED 72 SILVER LABEL with SENDit technology. The device is powered by the company's ENGINE platform.

According to the press release, stroke affects someone in the U.S. every 40 seconds, with one in every 21 people dying from the condition. A recent analysis estimates stroke mortality worldwide is projected to increase by 50% between 2020 and 2050.

"What sets THUNDERBOLT apart is the innovative design which minimizes catheter manipulation and promotes safe, complete clot capture," said Donald Frei, a neurointerventional radiologist at Swedish Medical Center in Denver.

David Fiorella, director of the Cerebrovascular Center at Stony Brook University Hospital, noted that "modulated aspiration may facilitate more consistent and complete clot removal when used in conjunction with standard aspiration thrombectomy catheters."

Penumbra claims THUNDERBOLT is the only computer assisted vacuum thrombectomy device available for stroke treatment in the U.S. The Alameda, California-based company develops medical devices for conditions including ischemic stroke, venous thromboembolism, and acute limb ischemia.

You May Also Be Interested In

• Synopsys upgraded at Piper Sandler on Intel foundry momentum, Apple opportunity
• FDA conditionally approves QYLEKI as brand name for Quoin drug
• SeaStar Medical's SCD therapy receives CMS billing codes for AKI