Bolt Medical announced the intravascular ultrasound (IVUS) results of 22 patients enrolled in the RESTORE FIH (First in Human) Coronary feasibility clinical trial using the company's Bolt IVL™ Coronary System for the treatment of coronary arterial disease with severely calcified lesions. Matthew J. Price, MD, Professor of Medicine and Director of the Cardiac Catheterization Laboratory in the Division of Cardiovascular Diseases at Scripps Clinic, La Jolla, California, presented the IVUS results of this prospective, observational, feasibility study during the TCT 2024 conference.
CARLSBAD, Calif., Oct. 28, 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 announced the intravascular ultrasound (IVUS) results of 22 patients enrolled in the RESTORE FIH (First in Human) Coronary feasibility clinical trial using the company's Bolt IVL™ Coronary System for the treatment of coronary arterial disease with severely calcified lesions. Matthew J. Price, MD, Professor of Medicine and Director of the Cardiac Catheterization Laboratory in the Division of Cardiovascular Diseases at Scripps Clinic, La Jolla, California, presented the IVUS results of this prospective, observational, feasibility study during the TCT 2024 conference.
Intravascular lithotripsy (IVL) has been shown to be a safe and effective treatment for severely calcified coronary lesions.* IVUS was used to evaluate how the Bolt IVL system facilitated optimal stent implantation. Twenty-two patients enrolled in the RESTORE FIH trial, a prospective, feasibility study designed to evaluate initial safety and effectiveness of the Bolt Medical IVL coronary catheter, had evaluable IVUS images at baseline and post-stent implantation. The Bolt IVL system features the unique CAD360™ design where each emitter station is comprised of 4 emitters equally spaced 90° apart. IVUS images were evaluated by an independent, core laboratory (VasCore, Boston, MA).
IVUS results post-IVL and stenting support the efficacy of the Bolt IVL system by achieving a minimal stent area (MSA) of 8.07 ± 2.48 mm2 with absolute stent expansion of 101% of expected diameter resulting in MSA > 5.0 mm2 in 95% and > 5.5 mm2 in 91% of patients. Stent delivery, implantation and post-dilation were successful in all cases.
Commenting on these results, Dr. Price, said, "The data from the Bolt FIH IVUS study are particularly exciting given the achieved MSA and stent expansion, as it supports the safety and efficacy of a novel approach to deliver lithotripsy energy for the treatment of severely calcified coronary lesions. I am looking forward to the results of the FRACTURE IDE trial, so that the potential benefits of this technology - including a uniform energy profile, more pulses, and ease of delivery - can help address the unmet needs of our patients undergoing complex PCI."
"The trial data confirms that the Bolt IVL laser-based mechanism of action with unique CAD360™ emitter design led to outstanding results measured by intravascular imaging that confirm the effect of the Bolt therapy on severe calcium," said Keegan Harper, Chief Executive Officer of Bolt Medical. "The positive clinical feedback on device performance and outcomes gives us tremendous confidence to move this innovative IVL platform forward in coronary arteries with a planned global IDE pivotal trial."
*JACC. 2020 Dec, 76 (22) 2635-2646
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 company is concurrently studying three unique catheter platforms for various arterial vessel beds. 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.
Caution: The Bolt IVL™ System is an investigational device, which is not yet cleared for commercial distribution in any country.
Bolt IVL™ and CAD360™ are trademarks 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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