First in Human Summary
First patients enrolled with successful results
FIH: 3 Patients Treated with PIVL
FIH PIVL Average Stenosis
Major Adverse Limb Events at 30 days
ZERO
Feasibility & Treatment Effect of PIVL on Calcified Lesions
Promising Results in Severely Calcified Cadaveric Limbs Demonstrate Ability to Shatter, and Expand Without Adjunctive Devices
1 When tested in two clinically relevant cadaveric models of peripheral artery disease, PIVL treatment was effective at simultaneously achieving luminal expansion and producing full- thickness calcium fractures in diseased arteries during a single treatment session.
2 PIVL was effective in modifying circumferential calcium over a wide range of thicknesses, and its effectiveness in modifying eccentric calcium increased as calcium thickness increased.
3 From a translational perspective, PIVL could be useful for the treatment of calcific lesions with characteristics that render them refractory to traditional angioplasty.
Shatter
Expand
Shatter and Expand
PIVL effectiveness in Cadaveric Intravascular Calcium
