Bolt IVL Above-the-Knee System Studied in RESTORE ATK Pivotal Trial

May 29, 2024—Bolt Medical, Inc. announced findings for the company’s new-generation intravascular lithotripsy (IVL) laser-based platform for the treatment of calcified cardiovascular disease.

According to the company, the RESTORE ATK pivotal clinical trial is evaluating the Bolt IVL above-the-knee (ATK) system for the treatment of peripheral artery disease with moderate to severe calcified lesions. The prospective, single-arm trial enrolled 95 patients to assess the safety and efficacy of the Bolt IVL system.

Principal investigator, Professor Marianne Brodmann, MD, presented the results from the first 60 patients enrolled in RESTORE ATK at LINC 2024, the Leipzig Interventional Course held May 28-31, in Leipzig, Germany. Prof. Brodmann is Head of Division of Angiology at the Medical University of Graz, Austria.

As summarized in the company’s press release, the primary safety endpoint of the trial was freedom from major adverse events (MAE) within 30 days after the index procedure. The primary efficacy endpoint was procedural success, defined as residual diameter stenosis < 50%.

Through 30 days, there were no reports of MAE including severe dissection, perforation, or unplanned target limb major amputation, and no clinically driven target lesion revascularization supporting the achievement of both the primary safety and efficacy endpoints in the trial.

“The RESTORE ATK trial demonstrated outstanding safety and efficacy in the 60 reported patients at 30 days,” commented Prof. Brodmann in Bolt Medical’s press release. “I am particularly impressed with the device outcomes as the enrolled patients had severe calcification with 26% of lesions being chronic total occlusions.”

Prof. Brodmann continued, “The Bolt IVL system’s increased pulses and targeted therapy provide advancements to address unmet needs of IVL therapy to treat these complex patients with stand-alone IVL therapy, importantly with a low 12% rate of postdilation required.”

The company advised that the successful completion of RESTORE ATK with the first 60 patients provides the powered data set for FDA 510(k) and European CE Mark regulatory submissions for the Bolt IVL ATK system, which is an investigational device not yet cleared for commercial distribution in any country.

On April 22, 2024, the company announced that RESTORE ATK completed enrollment.