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Prescient Medical Announces SECRITT I Trial Results For vProtect Luminal Shield

Prescient Medical, Inc. announced that six months after placement of a vProtect Luminal Shield to treat a "vulnerable" plaque, a follow-up exam revealed reduced plaque burden and reduced stenosis in the target vessel. The exam was part of the SECRITT I trial, a randomized study designed to evaluate the vProtect Luminal Shield as a prophylactic treatment for non-flow-limiting vulnerable plaques. The SECRITT I trial is sponsored and conducted by Erasmus University in Rotterdam. The 6-month follow-up exam was performed on May 20 by an interventional cardiology team led by Professor Patrick Serruys, the principal investigator for the SECRITT I study. Evelyn Regar, MD, PhD moderated the case at the EuroPCR congress in Barcelona. The vProtect Luminal Shield is manufactured by Prescient Medical, which plans to pursue a vulnerable plaque indication in the future.

The patient, a 75-year-old woman, was treated six months earlier for a culprit lesion in the left anterior descending coronary artery. At that time the SECRITT investigators, using a combination of imaging techniques, also located a vulnerable plaque in the patient’s left circumflex artery. The lesion was unremarkable by angiography (37% diameter stenosis); such lesions are usually not treated, even though vulnerable plaques are prone to rupture with potentially fatal consequences. A 3.5 mm vProtect Luminal Shield was placed in the vessel (reference vessel diameter 2.74 mm), resulting in a post-procedural stenosis of 30%.

The 6-month angiographic follow-up exam was performed per study protocol using a variety of imaging techniques: multi-slice CT, intravascular ultrasound (IVUS), IVUS-virtual histology (IVUS-VH), angiography, and optical coherence tomography (OCT).

The follow-up exam indicated that the self-expanding vProtect Luminal Shield had stabilized the vulnerable lesion while gently expanding over time. Imaging studies revealed that the residual stenosis in the area of the lesion improved from 30% to just 5% (measured by Quantitative Angiography). The Shield was covered by a thin layer of healthy tissue with an average thickness of 80 – 110 microns. These results are comparable to what is seen with drug eluting stents in terms of thickness–we did not see a significant hyperplastic injury response, commented cardiac pathologist Gary Tearney, MD, PhD. Dr. Tearney, an Associate Professor of Pathology at Harvard University and the Wellman Center for Photomedicine, went on to explain that The Shield appears to be perfectly designed for just this type of lesion–since it’s self-expanding, there is less chance of rupturing the plaque.

Prescient Medical views the SECRITT I trial as a significant step toward achieving its mission of reducing deaths from heart attacks. According to Prescient CEO Patricia Scheller, In the future, we hope that the Shield will be used to stabilize these soft, rupture-prone lesions without causing excessive injury to the vessel wall like traditional balloon-expandable stents. We are very encouraged by the healthy endothelial tissue coverage and reduced stenosis demonstrated in this patient.