Abstract No. 395 - Blockstent deployment results in immediate vascular occlusion

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Purpose To design a new medical device for occlusion of peripheral arteries, build a prototype, and complete an initial pilot nonclinical study comparing this new technology to an existing device. Materials and Methods A prototype of the Blockstent Microcatheter was designed and manufactured. A 6 mm diameter x 10 mm long cylindrical balloon made of gold with a 10 micron thick wall was manufactured using electroforming. The Blockstent was mounted on a 3.5 Fr microcatheter using an elastic sleeve to firmly hold the neck of the Blockstent onto the distal end of the microcatheter. The Blockstent was folded, wrapped and compressed onto the distal end of the microcatheter. A 0.018” nitinol wire was used as an obturator. A 6 Fr guide sheath was advanced into the right subclavian artery in a 25 kg dog and the compressed Blockstent was advanced into place, expanded, and detached from the delivery microcatheter by advancing the tip of the sheath and pulling back on the delivery microcatheter. An AMPLATZER Vascular Plug II was then deployed in the left subclavian artery using standard technique. Results The treatment phase of the study was completed in less than five minutes. The prototype demonstrated excellent fluoroscopic visibility, trackability and deliverability. The Blockstent expanded in a controlled manner at a pressure of less than 1 atmosphere, resulting in immediate occlusion of the target vessel. After deployment of the AMPLATZER Vascular Plug II there was flow through the device. Conclusion The Blockstent microcatheter is a promising new device for peripheral artery occlusion and offers the potential for short, simple treatments with rapid occlusion. A chronic nonclinical study is planned for 2013.