Bolt Medical today announced the results of the first 60 patients enrolled in the RESTORE ATK pivotal clinical trial using the company's Bolt IVLTM Above the Knee System for the treatment of peripheral arterial disease with moderate to severe calcified lesions as presented during the LINC 2024 conference in Leipzig, Germany.
CARLSBAD, Calif., May 29, 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 calcified cardiovascular disease.
Bolt Medical today announced the results of the first 60 patients enrolled in the RESTORE ATK pivotal clinical trial using the company's Bolt IVLTM Above the Knee System for the treatment of peripheral arterial disease with moderate to severe calcified lesions as presented during the LINC 2024 conference in Leipzig, Germany. Principal investigator, Professor Marianne Brodmann, Head of Division of Angiology at the Medical University of Graz, Austria, presented the results from the prospective, single-arm trial designed to assess the safety and efficacy of the Bolt IVL system in 95 enrolled patients.
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. The successful completion of RESTORE ATK with the first 60 patients provides the powered data set for 510(k) and CE Mark regulatory submissions for the Bolt IVL ATK System.
"The RESTORE ATK trial demonstrated outstanding safety and efficacy in the 60 reported patients at 30 days. I am particularly impressed with the device outcomes as the enrolled patients had severe calcification with 26% percent of lesions being chronic total occlusions (CTO). 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 post-dilation required." stated Professor Brodmann.
"We are thrilled with the results of the RESTORE ATK pivotal trial and thank all who made this possible, especially our physician investigators and research staff as well as their patients," said Keegan Harper, Chief Executive Officer of Bolt Medical. "The positive safety and efficacy data highlight the advanced features of our laser-based IVL and is another major milestone that will contribute to the company's first regulatory submission of the Bolt IVL ATK System."
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 unique 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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