Bolt Medical announces results of the first 28 patients in the RESTORE FIH Coronary IVL trial for the treatment of coronary arterial disease with the company's unique intravascular lithotripsy system.
CARLSBAD, Calif., May 16, 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 28 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 as presented during the EuroPCR 2024 conference in Paris, France. Andrius Berukstis PhD, MD, Associate Professor and site principal investigator at Vilnius University Hospital Santaros Clinic, Vilnius, Lithuania, presented the results from the prospective, single-arm observational feasibility trial.
The primary efficacy endpoint was procedural success, defined as successful stent delivery with a residual diameter stenosis <50% and freedom from in-hospital MACE. The primary safety endpoint of the study was freedom from MACE* within 30 days following the procedure. Both the primary efficacy and safety endpoints were achieved in the trial. Importantly there were no reports of severe dissection, perforation or abrupt closure complications adding to the overall safety of the Bolt IVL Coronary System. The safety and efficacy data supports initiation of an IDE pivotal study which will be used to support global regulatory submissions.
"The RESTORE FIH trial clearly demonstrated that the Bolt IVL Coronary System is able to fracture calcium enabling optimal stent expansion and has an excellent safety profile. Moreover, the catheter design provided excellent deliverability across difficult lesions," stated Dr. Berukstis.
Dr. Matthew Price, Professor of Medicine, Director Cardiac Catheterization Laboratory, Division of Cardiovascular Diseases, Scripps Clinic and clinical advisor to Bolt Medical added, "The data from the Bolt FIH study are particularly exciting, 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."
"This trial data confirms that the Bolt IVL laser-based mechanism of action with unique CAD360™ emitter design led to excellent efficacy and safety results," 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."
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 that will feature highly deliverable catheters, increased available therapy, and visible, directional emitters to direct 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
Media Relations, Bolt Medical, 1 760-392-3093, [email protected], www.boltmed.com
SOURCE Bolt Medical
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