Bolt IVL System’s RESTORE ATK Pivotal Trial Completes Enrollment

April 22, 2024—Bolt Medical, Inc. announced the completion of patient enrollment of the RESTORE ATK pivotal clinical trial. The trial is evaluating the Bolt intravascular lithotripsy (IVL) system for the treatment of above-the-knee (ATK) peripheral arterial disease with moderate to severe calcified lesions.

According to the company, the Bolt IVL ATK system is a new-generation laser-based platform for the treatment of calcified cardiovascular disease. It is designed to fracture intimal and deep calcium by creating acoustic pressure waves inside of a balloon catheter.

The data from RESTORE ATK, which will be presented later in 2024, will be used to support regulatory submissions for FDA 510(k) clearance and CE Mark approval.

As summarized in the company’s press release, the prospective, single-arm RESTORE ATK trial enrolled 95 patients at 11 centers across Europe to assess the safety and efficacy of the Bolt IVL system. The study is led by Principal Investigator Professor Marianne Brodmann, MD, who is the head of Division of Angiology at the Medical University of Graz in Graz, Austria.

“Effective calcium modification remains one of the toughest challenges in treating peripheral artery disease,” commented Prof. Brodmann in Bolt’s press release. “The RESTORE ATK trial enrolled patients with severe calcification and a high percentage of chronic total occlusions. Further, female patients, another challenging patient cohort, were significantly represented within the trial as well.”

The company advised that the Bolt IVL system is an investigational device, which is not cleared for commercial distribution in any country. Bolt Medical noted that the company is concurrently studying three unique catheter platforms for various arterial vessel beds.