Optimal Tissue Debulking Protocol Defined for Treating In-Stent Restenosis (ISR) with Boston Scientific’s JETSTREAM® Navitus Atherectomy Device

CBSET data disclosed at Cardiovascular Research Technologies (CRT) 2015

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LEXINGTON, Mass.--()--CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, announced today that its scientists have defined the optimal tissue debulking protocol for treating in-stent restenosis (ISR) with Boston Scientific’s JETSTREAM® Navitus atherectomy device. These findings were disclosed this week at the “CRT 2015” annual scientific meeting in Washington, D.C., Feb. 21-24.

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 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.

“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,” 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.

The results of two related studies also were disclosed at “CRT 2015”:

  • “Minimal Plaque Surface Area and Minimal Luminal Area Needed for Effective Atherectomy using the JetStream Navitus in Treating In-Stent Restenosis of Femoral Artery in a Porcine Model” (Nicolas W Shammas, MD, MS1, Nicole Aasen2, Lynn Bailey3, Jay Budrewicz3, Trent Farago2, Gary Jarvis2; From the 1Midwest Cardiovascular Research Foundation, Davenport, IA; 2Boston Scientific, Maple Grove, MN; 3CBSET Inc, Lexington, MA).
  • “Intravascular Ultrasound Assessment of the Optimal Number of Runs Using the JetStream Navitus Device to Achieve Maximum Tissue Debulking in Femoral Artery in-Stent Restenosis Porcine Model” (Nicolas W Shammas, MD, MS1, Nicole Aasen2, Lynn Bailey3, Jay Budrewicz3, Trent Farago2, Gary Jarvis2; From the 1Midwest Cardiovascular Research Foundation, Davenport, IA; 2Boston Scientific, Maple Grove, MN; 3CBSET Inc, Lexington, MA)

For copies of these abstracts, or to learn more about CBSET, please contact: Dr. Erica Smith, Director, Business Development: +1-781-296-5319, esmith@cbset.org

About CBSET

CBSET — Concord Biomedical Sciences & Emerging Technologies — is the preclinical research leader in critically important 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. CBSET occupies a 35,000-square-foot, state-of-the-art facility near Boston that includes a vivarium, catheterization/imaging labs, surgical suites, dedicated labs for SEM, histopathology/pathology, and drug metabolism and pharmacokinetics. CBSET offers the latest equipment for fluoroscopy, echocardiography (TEE/TTE), electrophysiology, IVUS, optical coherence tomography (OCT), endoscopy/laparoscopy, surgical video recording, histology, microradiography, and SEM (Scanning Electron Microscopy).

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, +1-508-359-4005, x108
APR, President

Release Summary

Optimal tissue debulking protocol defined for treating in-stent restenosis (ISR) with Boston Scientific’s JETSTREAM® Navitus atherectomy device

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, +1-508-359-4005, x108
APR, President