First in Human Summary

First patients enrolled with successful results

FIH: 3 Patients Treated with PIVL™

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Human Summary Chart Left

FIH PIVL™ Average Stenosis

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Human Summary Chart Right

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

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Successful calcium fragmentation
Successful calcium fragmentation

Expand

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Successful device delivery and luminal gain
Successful device delivery and luminal gain

Shatter and Expand

PIVL™ effectiveness in Cadaveric Intravascular Calcium

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Shatter and Expand Chart