Silk Road Medical Announces Post Approval Study for the Treatment of Standard Surgical Risk Patients using TCAR

Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced a prospective study to evaluate the TCAR® system in the treatment of standard surgical risk patients with carotid artery disease.

The post-market study, called ROADSTER 3, will fulfill the U.S. Food and Drug Administration’s (FDA) condition of approval for the recent expansion of labeling for the ENROUTE® Transcarotid Stent System, which now includes patients at high and standard risk of complications from carotid endarterectomy (CEA).

“ROADSTER 3 presents a significant opportunity to further build on the substantial clinical evidence supporting TCAR,” said Erica Rogers, President and Chief Executive Officer of Silk Road Medical. “Strong clinical evidence has always been the backbone of our strategy to drive adoption, and to ensure every eligible patient has access to a less invasive treatment option.”

ROADSTER 3 is a prospective, multi-center, single-arm study designed to assess the real-world treatment of standard surgical risk patients with carotid artery disease using TCAR. The study targets a maximum enrollment of 400 patients across approximately 50 sites, and the primary endpoints include a composite of major adverse events (death, stroke, or myocardial infarction) through 30 days post-procedure, plus ipsilateral stroke from day 31 to 365 post-procedure. The incidence of cranial nerve injury within 30 days post-procedure is a key secondary endpoint. The study is led by Co-National Principal Investigators: Dr. Marc L. Schermerhorn, Chief, Division of Vascular and Endovascular Surgery at Beth Israel Deaconess Medical Center, Dr. Meghan Dermody, Chief, Division of Vascular Surgery at Lancaster General Hospital, and Dr. Jeffrey Jim, Chief of Vascular and Endovascular Surgery, Allina Health Minneapolis Heart Institute.

“This study is providing physicians with the unique opportunity to participate in a first-ever prospective study to demonstrate the safety and efficacy of TCAR among the standard surgical risk patient population,” said Dr. Jeffrey Jim. “I’m honored to be included as Principal Investigator and eagerly await clinical results that will help expand a less invasive treatment option for carotid patients regardless of their surgical risk.”

For more information on the ROADSTER 3 study protocol, visit: https://clinicaltrials.gov/ct2/show/NCT05365490

About Silk Road Medical’s TCAR Procedure with the ENROUTE Transcarotid Neuroprotection and Stent Systems
TransCarotid Artery Revascularization is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. The ENROUTE Transcarotid Stent is intended to be used in patients at high risk and standard risk for complications from CEA, in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) during the procedure. The ENROUTE Transcarotid NPS is a first in class device used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the ENROUTE Transcarotid Stent.

Hot this week

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”

Avery Dennison Medical Introduces Ipdated SilFoam Lite: Sustainability, MDR Certification & Performance Improvements

The newly enhanced SilFoam Lite delivers superior efficiency and reliability, bringing improved fluid handling capabilities and improved tack. These improvements make the product ideal for customers seeking quality, high-performance solutions in wound care notes Avery Dennison Medical.

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

New advancements in the AiBLE Spine Surgery ecosystem build upon the company's commitment to procedural innovation and execution