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.
"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.
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,
media@boltmed.com, www.boltmed.com
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SOURCE Bolt Medical