FDA Clears Silk Road Medical’s Next-Generation Enroute Transcarotid Neuroprotection System
April 13, 2016—Silk Road Medical, Inc. announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s next-generation Enroute transcarotid neuroprotection system (NPS), which is specifically designed and indicated for transcarotid artery revascularization (TCAR). On March 16, the company announced European CE Mark approval for the next-generation Enroute transcarotid NPS.
The new Enroute NPS will immediately be launched in the United States and will be included in the ongoing multicenter ROADSTER 2 postapproval study that is assessing TCAR in the real-world treatment of patients at risk for stroke due to carotid artery disease. The prospective study will enroll a minimum of 600 patients at up to 100 sites.
In the company’s announcement, Vikram Kashyap, MD, National Coprincipal Investigator of ROADSTER 2, commented, “Our experience suggests that the new Enroute NPS is a major step forward in transcarotid design and engineering. The ROADSTER 2 study will further build the clinical evidence base for the new Enroute NPS and the incredibly promising TCAR procedure.” Dr. Kashyap is Chief of Vascular and Endovascular Surgery at University Hospitals Case Medical Center in Cleveland, Ohio.
The company stated that TCAR is a clinically proven procedure, combining the surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk for causing stroke.
According to Silk Road Medical, the Enroute NPS allows the physician to directly access the common carotid artery in the neck and initiate high-rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting Silk Road's Enroute transcarotid stent. The enhanced next-generation device provides physicians with an even more dependable and easy-to-use system to treat patients in the safest manner possible, stated the company.
Wesley Moore, MD, performed the first TCAR case with the new device in the United States. Dr. Moore is Professor and Chief (Emeritus), Division of Vascular Surgery, at Ronald Reagan UCLA Medical Center in Los Angeles, California.
In the company’s press release, Dr. Moore commented, “The best prospect for reducing the periprocedural risk of stroke during carotid revascularization has been the TCAR procedure, and the technical advancements of the new Enroute NPS provide us with even more confidence to safely treat patients in a minimally invasive manner.”
In February 2015, Silk Road announced FDA clearance for the first-generation Enroute transcarotid NPS, which was supported by the results of the pivotal ROADSTER clinical trial. In May 2015, the company announced FDA approval for the Enroute transcarotid stent system.
The ROADSTER investigators concluded, “The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS [carotid angioplasty and stenting]." The next-generation Enroute NPS was designed with the same flow-rate specifications to maintain the excellent neuroprotection seen in the ROADSTER trial, noted Silk Road Medical.