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
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 and Expand
PIVL effectiveness in Cadaveric Intravascular Calcium