It Takes Two Runs to Achieve Optimal In-Stent Restenosis Tissue Debulking

This week has seen the holding of the Cardiovascular Research Technologies, “CRT 2015” annual scientific meeting in Washington, D.C. Not-for-profit preclinical research institute, CBSET, has used the occasion to announce that its scientists have defined the optimal tissue debulking protocol for treating in-stent restenosis (ISR) with Boston Scientific’s JETSTREAM® Navitus atherectomy device.


This week we’ve already reported study findings from CBSET that show improved uptake of drug coatings from Drug-Eluting Balloons when effective atherectomy has been performed. Completing the jigsaw the research institute tells us just how to achieve optimal debulking of plaque using Boston Scientific’s JETSTREAM Navitus atherectomy device.

The preclinical study presented at the CRT event was entitled “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.”

The upshot from the work is that it seems the Boston Scientific JETSTREAM Navitus atherectomy device achieved optimal tissue debulking after two blade-up (BU) 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. Prior to this study, the number of runs needed to achieve optimal tissue debulking in ISR using the JETSTREAM Navitus device was unknown.

Investigator comments

“Now we may proceed to translate these findings into clinical data, with the goal that optimal tissue removal or debulking will translate into better patient outcomes, and 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,” concluded the study’s principal investigator, Nicolas W. Shammas, MD, President and Research Director, Midwest Cardiovascular Research Foundation.

“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,” said Peter Markham, President, CEO and a co-founder of CBSET.

Source: CBSET

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