For Calcified Lesions

SilverHawk-R LS-C

Conquer Calcium

The SilverHawk-R LS-C Peripheral Plaque Excision System for surgical use, “RockHawk,” is the latest addition to the SilverHawk family of products, enabling physicians to treat de novo and restenotic calcified and non-calcified lesions located in native peripheral arteries. The new device incorporates design changes in the cutting blade that reduce the force needed and has the potential to reduce time to cut through calcified lesions.

Rock Solid Design

The RockHawk system is based on the SilverHawk Peripheral Plaque Excision System that was originally cleared for use in the U.S. in 2003. This model incorporates changes in the geometry and the material of the cutter structure giving it more mass and durability to facilitate the break down of complex, hard, calcified lesions that may be resistant to conventional treatment. The RockHawk also features a floating ramp that gives the cutter better suspension allowing it to stay engaged against the lesion, similar to the pivot heads of a razor.

Conquering new grounds

“The RockHawk system enables us to treat a lesion morphology that has traditionally been very difficult to treat,” said Dr. Glen Schwartzberg, a Vascular Surgeon from Baton Rouge, LA, after doing the first two RockHawk case’s in the US. “The surgical cut-down approach using the RockHawk allowed the treatment of lesions which could not be accessed using the traditional percutaneous approach and I found that the new cutter is markedly better in cutting and engaging calcified lesions. In one particular case, I was able to avoid what would been a very challenging bypass on a patient with severe disease.”

The Ultimate Frontier

In late January 2008, ev3 submitted an IDE application to the FDA for the study of the SilverHawk-R LS-C Peripheral Plaque Excision System in combination with the SpiderFX Embolic Protection Device for treatment of moderate to severely calcified peripheral arterial disease. The protocol submitted is for a prospective, multi-center study that would enroll over 100 patients to evaluate the safety and effectiveness of the SpiderFX and the SilverHawk-R LS-C for capture containment and removal of excised plaque and embolic debris during endovascular treatment of moderate to severely calcified peripheral arterial disease.