Bolt Medical has announced the completion and positive results of the RESTORE ATK and RESTORE BTK pivotal clinical trials, evaluating the company's Bolt intravascular lithotripsy (IVL) system for treating peripheral arterial disease (PAD) in patients with moderate to severe calcified lesions. The findings were presented at VIVA 2024 by Thomas Zeller (University Heart Centre Freiburg-Bad Krozingen).
RESTORE ATK Trial Results
The RESTORE ATK trial enrolled 95 patients in a prospective, single-arm study to determine the safety and efficacy of the Bolt IVL system in the superficial femoral and popliteal arteries. Marianne Brodmann (Medical University of Graz) led the trial as principal investigator. The primary safety endpoint, freedom from major adverse events (MAE) within 30 days, was met with no reports of severe dissection, perforation, or unplanned target limb major amputation. The primary efficacy endpoint, procedural success (defined as residual diameter stenosis <50%), was also achieved. These results support both the safety and efficacy of the Bolt IVL system in this patient population.
RESTORE BTK Trial Results
The RESTORE BTK trial was a prospective, single-arm study involving 20 patients with moderate to severe calcified infrapopliteal arteries. Conducted across three European centers and led by Michael Lichtenberg (Arnsberg Clinic), the trial assessed the Bolt IVL system's safety and efficacy. Similar to the ATK trial, the primary safety endpoint (freedom from MAE within 30 days) was met with no reports of severe dissection, perforation, or unplanned target limb major amputation. The primary efficacy endpoint, acute reduction in percent diameter stenosis of the target lesion, was also achieved, indicating the system's effectiveness in treating these challenging lesions.
Expert Commentary
Michael Lichtenberg noted the challenges in treating patients in the RESTORE BTK trial with traditional IVL therapy. He highlighted the improved deliverability and crossability of the Bolt IVL catheter, which facilitated access to complex lesions. Lichtenberg also emphasized the benefit of visible emitters on the catheter, allowing for direct focus of acoustic energy on areas of persistent calcification.
Company Perspective
Keegan Harper, CEO of Bolt Medical, expressed pride in achieving these clinical milestones. He stated that Bolt IVL is positioned to expand the peripheral market and advance patient care, as the company plans regulatory submissions for both peripheral devices in the near future. The data presented at VIVA 2024 will be used to support US Food and Drug Administration (FDA) and CE mark regulatory submissions.
