J. Burpee, Flexible Stenting Solutions Inc., Eatontown, NJ; B. Beach , Flexible Stenting Solutions Inc. , Eatontown, NJ; A. Filachek, Burpee Materials Technology, LLC, Eatontown, NJ
The upper leg has arteries which include the superficial femoral and popliteal (SFA/Pop) arteries. Like the coronary arteries, plaque can accumulate in these arteries resulting in peripheral artery disease. This disease is characterized by long occlusions or blockages in the leg. During walking, stair climbing and other normal activities, the arteries can dramatically bend, rotate, elongate and compress as the knee flexes. The motion of the arteries and the need for a stent to move with the artery presents a difficult stenting challenge. First generation and second self expanding stents have lacked critical attributes required to satisfy all the needs presented in these arteries. A dedicated SFA/Pop stent that offers flexibility, durability and strength without compromising conformability or introducing trauma, and that can easily and accurately be delivered into the body is required to answer the current unmet clinical needs. An early historical criteria of stent design included maximizing connectivity in a stent while optimizing other properties. Over 10 year ago, there was a push in stent design for greater flexibility during delivery. In later years, there was another push in stent design towards flexibility after deployment. In many cases, and with the greater requirements for stent performance being imposed, the connectivity criterion was diminished over the last several generations of stents. A novel fully connected stent has been developed which offers great flexibility, durability, strength, and other optimal. The inherent double helix design and connectivity offers a unique stent that can move with the vessel while giving the support required of the stent. This platform, while developed with SFA/Pop arteries in mind, offers a stenting solution throughout the body. Keywords:
Fatigue, bending, flexibility, durability, conformability, nitinol, self expanding stent, medical device, superficial femoral, popliteal, femoropopliteal
