Study Defines Optimal Tissue Debulking Protocol for Boston Scientific's Jetstream Navitus to Treat In-Stent Restenosis

February 25, 2015—Concord Biomedical Sciences & Emerging Technologies (CBSET) announced that its scientists have defined the optimal tissue debulking protocol for treating in-stent restenosis (ISR) with Boston Scientific Corporation’s Jetstream Navitus atherectomy device. These findings were disclosed at CRT.15, the Cardiovascular Research Technologies annual scientific meeting, held February 21–24 in Washington, DC.

The study (“Optimal Number of Runs Using the Jetstream Navitus Device to Achieve Maximum Tissue Debulking of In-Stent Restenosis in a Porcine Stent/Balloon Injury Overstretch Model”) determined that the Jetstream Navitus atherectomy device achieved optimal tissue debulking after two blade-up runs, with no further gain in debulking after the second run. This study also confirmed that stent damage was minimal after the procedure, with no disruption to stent struts or stent integrity. Before this study, the number of runs needed to achieve optimal tissue debulking in ISR using the Jetstream Navitus device was unknown, noted CBSET.

The study’s principal investigator is Nicolas W. Shammas, MD, President and Research Director of Midwest Cardiovascular Research Foundation. In the CBSET press release, Dr. Shammas concluded, “Now we may proceed to translate these findings into clinical data, with the goal that optimal tissue removal or debulking will translate into (1) better patient outcomes and (2) ideal coupling with adjunctive therapies such as drug-coated balloons. We believe that the optimal debulking process will give physicians the best acute procedural results and hopefully better long-term outcomes.”

Peter Markham, President and Chief Executive Officer of CBSET, added, “The revascularization of peripheral arteries with significant plaque burden remains technically challenging. Debulking has emerged as an important tool to decrease the volume of the atherosclerotic plaque. Our study provides important guidance on atherectomy procedures designed to contribute to superior primary patency after revascularization while minimizing the risk of stent damage or other complications.”

CBSET is a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies. CBSET conducts preclinical research in therapeutic fields such as interventional cardiology, renal disease and dialysis, chronic drug-resistant hypertension, women’s health, minimally invasive surgery, orthopedics, biological and synthetic tissue repair, drug delivery, bioresorbable devices, and combination medical device and drug-eluting products.