Self-Expanding Intracoronary Prosthesis Limits Arterial Injury

A self-expanding luminal shield is designed to limit the arterial injury that typically occurs when cardiac stents are deployed.

The vProtect luminal shield is designed to treat soft, atherosclerotic lesions that may be at risk of rupture, or recently ruptured. The vProtect has ultra-thin struts to promote healing, and maintains an intrinsic radial force that matches the vessel compliance. The shield also provides robust biocompatible support for the vessel to ensure that the target coronary artery will remain open after placement. Three patients with established cardiac ischemia became the first recipients of the vProtect luminal shield in surgery performed in Columbia during May 2008. In the first patient, a 75% occlusion in the mid-circumflex coronary artery underwent pre-dilatation at low pressure with a 2.5 x 9 mm balloon and then received a 3.5 x 15 mm luminal shield. After gentle post-dilatation, angiography revealed that blood flow had been restored to the distal portion of the treated vessel. In the second patient, an 80% occlusion in the middle of the left anterior descending (LAD) branch required pre-dilatation with a 2.5 x 9 mm balloon. Additional lumen gain was achieved by shield placement and post-dilatation, again achieving restoration of blood flow distal to the treated segment.

The third patient was a challenging case with a 65% occlusion in the mid-LAD, located in a bend near a side branch ostium. The vProtect was chosen for this patient based on its mechanical properties, including high vascular conformability. Because of its flexibility, the vProtect was able to access the tortuous anatomy and cross the lesion successfully. Restoration of blood flow was achieved without angiographic evidence of straightening of the target vessel, a common occurrence with rigid balloon-expandable stents. In addition, the side branch was preserved without evidence of plaque shifting or worsening stenosis. The vProtect Luminal Shield is being developed by Prescient Medical (Doylestown, PA, USA), and is currently limited by U.S. federal law to investigational use only.

"The vProtect luminal shield and delivery system performed extremely well,” said Juan F. Granada, M.D., of the Cardiovascular Research Foundation (New York, NY; USA) who performed the surgery together with Juan Delgado, M.D., at the Corbic Institute-MUA (Envigado [near Medellin], Colombia). "The three patients we treated presented with lesions representative of what we see in daily clinical practice and we were able to cross these lesions and deliver the device safely in each case.”


Related Links:
Prescient Medical
Corbic Institute-MUA