Bolt Medical has announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the company’s Bolt intravascular lithotripsy (IVL) above-the-knee (ATK) and below-the-knee (BTK) systems for the treatment of peripheral arterial disease (PAD) in patients with moderate to severe calcified lesions.
RESTORE ATK enrolled 95 patients in the prospective, single-arm trial designed to assess the safety and efficacy of the Bolt IVL system in the superficial femoral and popliteal arteries. The study was led by principal investigator Marianne Brodmann (Medical University of Graz, Graz, Austria).
The primary safety endpoint of the trial was freedom from major adverse events (MAE) within 30 days following 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 revascularisation supporting the achievement of both the primary safety and efficacy endpoints in the trial.
RESTORE BTK is a prospective, single-arm trial designed to assess the safety and efficacy of the Bolt IVL system in 20 enrolled patients with moderate to severe calcified infrapopliteal arteries. The study was conducted at three centres across Europe and led by principal investigator Michael Lichtenberg (Arnsberg Clinic, Arnsberg, Germany).
The primary safety endpoint of the trial was freedom from MAE within 30 days following the index procedure. The primary efficacy endpoint was procedural success, defined as acute reduction in percent diameter stenosis of the target lesion. 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 revascularisation supporting the achievement of both the primary safety and efficacy endpoints in the trial.
“The patients treated in the RESTORE BTK trial presented challenges to traditional IVL therapy. The improved deliverability and crossability of the Bolt IVL catheter accessed complex lesions with ease. Moreover, the visible emitters on the Bolt IVL catheter provided me with the ability to directly focus acoustic energy on areas of persistent calcification,” said Lichtenberg in a Bolt Medical press release.
“The Bolt team is proud to accomplish these major clinical milestones with the completion of both the RESTORE ATK and RESTORE BTK pivotal trial,” said Keegan Harper, chief executive officer of Bolt Medical. “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.”
Bolt Medical notes that the data presented at VIVA 2024 will be used to support US Food and Drug Administration (FDA) and CE mark regulatory submissions.
