The New Generation of IVL

The new generation of Intravascular Lithotripsy (IVL) delivering clinical benefits – Advanced laser-based
platform that delivers consistent acoustic output with inherent advantages over commercially available IVL platforms

Advanced Therapy

Increased available therapy (pulses) to
maximize the usability of each catheter
in all types of calcified procedures

Deliverability

Deliverability when it matters with
low crossing profiles, robust
pushability and trackability

Visibility

Visible, directional emitters with on/off
selectivity to direct energy to concentric,
eccentric and nodular calcium lesions

“We require novel technology to address the unmet needs of intravascular lithotripsy: improved deliverability, more pulses and a consistent and targeted acoustic profile to treat the broad range of calcified lesions that are encountered during complex PCI. I am excited for Bolt to take IVL to a new level, which will enable operators to safely and effectively treat the most challenging anatomies.”
– Matthew Price, MD, Professor of Medicine, Director, Cardiac Catheterization Laboratory, Division of Cardiovascular Diseases, Scripps Clinic

Clinical Need

Over 30% of patients treated for percutaneous coronary intervention in the United States have some degree of calcium, a 31% increase over the last two decades.¹ In asymptomatic patients presenting for preventative care, 61% of patients displayed atherosclerotic calcification in either carotid, coronary, proximal and distal aorta or iliac vessel beds.² Vascular calcification is a significant challenge that defines the limits of acute procedural and device success and limits the clinical durability of the intervention.³Calcium can make it difficult to dilate lesions which can lead to vessel dissection, stent underexpansion and higher risk of complications. .

¹ Généreux, P. et al. J Am Coll Cardiol 2014 May;63(18):1845-1854.
² Hirsch AT, et al. Circulation 2006;113:e463–e654.
³ Rocha-Singh, K. et al. Catheter Cardiovasc Interv. 2014 May 1;83(6):E212-20

New Generation Bolt IVL^TM Mechanism of Action⁴

Laser and Optics MOA

Laser energy is distributed through optical fibers then converted to acoustic pressure waves by generating a plasma event within a balloon inflated at low pressure
Initial pressure waves fracture calcification
Secondary cavitation bubble pressure further expands fractures in the calcium

⁴ Adapted from Phys.Chem. Chem. Phys., 15, 3027