May 30, 2008 - Three patients with established cardiac ischemia recently became the first recipients of the vProtect Luminal Shield, a self-expanding intracoronary prosthesis designed to limit arterial injury that typically occurs when stents are deployed.
The Shield reportedly also provides robust biocompatible support for the vessel to ensure that the target coronary artery will remain patent after placement.
The patients were treated May 8-9 by Juan F. Granada, M.D., (Cardiovascular Research Foundation, New York, NY) and Juan A. Delgado, M.D., (Corbic Institute-MUA) at the Corbic Institute-MUA in Envigado, Colombia. The target lesions ranged from 60 percent to 80 percent stenosis before the vProtect Luminal Shields were deployed.
In the first patient, a 75 percent 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 percent 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 Luminal Shield was chosen for this patient based on its mechanical properties, including high vascular conformability. Because of its flexibility, the vProtect Luminal Shield was able to access the tortuous anatomy and cross the lesion successfully. Restoration of 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 and delivery system performed extremely well," according to Dr. Granada. "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. Although the vProtect Luminal Shield has ultra-thin struts to promote healing, it maintains an intrinsic radial force that matches the vessel compliance. I am very pleased with these early results," Dr. Granada said.
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April 17, 2024 
