SUNNYVALE, Calif., Nov. 2, 2015 /PRNewswire/ -- Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced the first patient was enrolled in the US ROADSTER 2 post approval study by Vascular Specialists at Greenville Memorial Hospital in Greenville, South Carolina. ROADSTER 2 is a prospective, multi-center study designed to assess the real world treatment of patients at risk for stroke due to carotid artery disease with the recently FDA-approved ENROUTE® Transcarotid Neuroprotection (NPS) and Stent System, the first devices designed specifically for TCAR – TransCarotid Artery Revascularization. The prospective study will include a minimum of 600 patients at up to 100 sites and is being led by Co-National Principal Investigators Dr. Peter Schneider, Chief of Vascular at Kaiser Foundation Hospital in Honolulu, Hawaii, and Dr. Vikram Kashyap, Chief of Vascular and Endovascular Surgery, University Hospitals Case Medical Center, Cleveland, Ohio.
Stroke is a leading cause of death and life-altering disability. Every year, there are over 675,000 ischemic strokes in the US alone, and an estimated 20-30% of these are caused by disease in the carotid arteries which carry blood to the brain. If left untreated, these blockages can fragment, flow to the brain and lead to a potentially disabling stroke, also known as a "brain attack."
"TCAR with the ENROUTE Transcarotid system represents the modernization of carotid repair." said Dr. Bruce Gray, who performed the procedure with his colleagues Dr. Mark Androes and Dr. Joseph Blas. "With traditional surgical repair where we cut open the neck and carotid artery, there is always an underlying risk of serious complications including heart attack and nerve injury. The TCAR procedure combines surgical principles of protecting the brain with advanced endovascular stent technology to treat patients in a far less invasive and safe manner."
The ROADSTER 2 study is a follow up to the ROADSTER study, which evaluated the TCAR procedure in 141 patients at high risk for complications from surgery with a composite primary endpoint result of 3.5% Stroke (S), Death (D), or Myocardial Infarction (MI) through 30 days. "In the ROADSTER study we achieved the lowest reported 30-day stroke rate of any prospective study of carotid revascularization at 1.4% in the Intent to Treat patient population and 0.7% in the Per Protocol population." said Dr. Kashyap. "Importantly, there were no strokes in high risk subgroups, including symptomatic patients, elderly patients over the age of 75, and female patients. We look forward to building upon this excellent clinical evidence base in the ROADSTER 2 study."
"We have been seeking a less invasive alternative to traditional carotid surgery," said Dr. Schneider. "With TCAR and the ENROUTE transcarotid platform we have incorporated decades of learning from surgical and endovascular techniques into a hybrid procedure that has shown impressive clinical results to date. Dr. Kashyap and I are looking forward to partnering with the ROADSTER 2 investigators to evaluate this important innovation. This is a real opportunity to impact stroke prevention efforts in the US and around the world."
About Silk Road Medical
Silk Road Medical, Inc. is a private company located in Sunnyvale, CA, that develops and manufactures less-invasive medical devices intended to improve the treatment of carotid artery disease through proprietary transcarotid therapies. Detailed information can be found at www.silkroadmed.com.
About TCAR with the ENROUTE Transcarotid Neuroprotection and Stent System
The ENROUTE Transcarotid Stent is indicated for use in High Surgical Risk patients and is intended to be used in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) during the TCAR 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.
ENROUTE is a registered trademark of Silk Road Medical, Inc.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please refer to package insert for indications, contraindications, warnings, precautions, and instructions for use.
SOURCE Silk Road Medical, Inc.