Bolt Medical Announces Completion of Enrollment of RESTORE ATK Pivotal Trial for the Unique Bolt Intravascular Lithotripsy System
Bolt Medical completes the enrollment of RESTORE ATK pivotal trial for the treatment of peripheral arterial disease with its unique intravascular lithotripsy system.
CARLSBAD, Calif., April 22, 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 completion of patient enrollment of the RESTORE ATK pivotal clinical trial using the company's Bolt IVL™ Above the Knee System for the treatment of peripheral arterial disease with moderate to severe calcified lesions. The data from RESTORE ATK, which will be presented later in 2024, will be used to support FDA 510k and CE Mark regulatory submissions.
The prospective, single-arm trial is designed to assess the safety and efficacy of the Bolt IVL system in 95 enrolled patients. The study was enrolled in 11 centers across Europe and led by principal investigator Professor Marianne Brodmann who serves as the Head of Division of Angiology at the Medical University of Graz, Austria.
"Effective calcium modification remains one of the toughest challenges in treating peripheral artery disease. The RESTORE ATK trial enrolled patients with severe calcification and a high percentage of chronic total occlusions (CTO). Further, female patients, another challenging patient cohort, were significantly represented within the trial as well. The Bolt IVL system's unique energy platform, that offers increased pulses and targeted therapy provides a new generation of IVL that advances my ability to treat patients with calcified lesions." stated Professor Brodmann.
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 direct consistent energy for the treatment of concentric, eccentric and nodular calcium lesions.
"Intravascular lithotripsy therapy represents one of the fastest growing medical device markets. Bolt IVL is positioned to expand the market and advance patient care with our unique laser-based energy platform," said Keegan Harper, Chief Executive Officer of Bolt Medical. "Our team is rapidly innovating the Bolt IVL system for coronary and peripheral arterial disease. We are proud to accomplish this major milestone of completing the enrollment of the RESTORE ATK 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.
Caution: The Bolt IVL™ System is an investigational device, which is not yet cleared for commercial distribution in any country.
Bolt IVL™ is the trademark of Bolt Medical, Inc.
Media Contact
Media Relations, Bolt Medical, 1 760-392-3093, media@boltmed.com, www.boltmed.com
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SOURCE Bolt Medical
