Bolt Medical today announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the company's Bolt IVLTM Above the Knee (ATK) and Below the Knee (BTK) systems for the treatment of peripheral arterial disease in patients with moderate to severe calcified lesions. The data from both studies was presented today in the Late Breaking Clinical Trials session at the VIVA 2024 conference and will be used to support FDA and CE Mark regulatory submissions.
CARLSBAD, Calif., Nov. 4, 2024 /PRNewswire-PRWeb/ -- Bolt Medical, Inc., A clinical stage medical device company is developing a new generation intravascular lithotripsy (IVL) advanced laser-based platform with inherent advantages over commercially available IVL devices for the treatment of coronary and peripheral arterial calcification.
Bolt Medical today announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the company's Bolt IVLTM Above the Knee (ATK) and Below the Knee (BTK) systems for the treatment of peripheral arterial disease in patients with moderate to severe calcified lesions. The data from both studies was presented today in the Late Breaking Clinical Trials session at the VIVA 2024 conference and will be used to support FDA and CE Mark regulatory submissions.
RESTORE ATK enrolled 95 subjects 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 Professor Marianne Brodmann, Head of Division of Angiology at the Medical University of Graz, Austria. The primary safety endpoint of the trial was freedom from MAE (Major Adverse Events) 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 revascularization 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 3 centers across Europe and led by Principal Investigator Dr. Michael Lichtenberg, Chief Medical Officer and Director of the Angiology Department and Vascular Center at the Arnsberg Clinic in 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 revascularization 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 Dr. Lichtenberg.
"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."
About Bolt Medical, Inc.
Bolt Medical is focused on the design and development of innovative IVL catheters used in coronary and peripheral interventional procedures, particularly in patients with moderate to severe calcified arterial disease. The Bolt IVL system is designed to fracture intimal and deep calcium by creating acoustic pressure waves inside of a balloon catheter and will feature increased available therapy, a highly deliverable catheter, and visible, directional emitters to target consistent energy for the treatment of concentric, eccentric and nodular calcium lesions. The company is concurrently studying three catheter platforms for various arterial vessel beds.
Caution: The Bolt IVLTM System is an investigational device, which is not yet cleared for commercial distribution in any country.
Bolt IVLTM is the trademark of Bolt Medical, Inc.
Media Contact
Bolt Medical, Bolt Medical, 1 760-392-3093, [email protected], www.boltmed.com
SOURCE Bolt Medical
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