FDA Approves Silk Road Medical’s Enroute Transcarotid Stent System
May 19, 2015—Silk Road Medical, Inc. announced the company has received premarket approval (PMA) from the US Food and Drug Administration (FDA) for the Enroute transcarotid stent system.
According to Silk Road Medical, the Enroute transcarotid stent system is introduced and implanted into the carotid artery through a direct common carotid access point to enable a safe and more direct approach to carotid artery stenting. The Enroute stent is indicated for use in high-surgical risk patients and is intended to be used in conjunction with company’s Enroute transcarotid neuroprotection system (NPS), which received FDA 510(k) clearance in February 2015.
Used together, the Enroute stent system and NPS enable a hybrid transcarotid artery revascularization (TCAR) procedure. The Enroute transcarotid NPS is 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 Entoute transcarotid stent.
In Silk Road Medical’s press release, Prof. Ralf Kolvenbach, MD, commented, “TCAR allows us to avoid potential stroke hazards at the aortic arch while placing a stent under robust flow reversal which simulates the superb neuroprotection of carotid endarterectomy. With the Enroute transcarotid stent, we now have a dedicated, ergonomic stent platform for TCAR that combines the control afforded by transcarotid access with the stent’s visibility under X-ray, allowing for confident, precise stent placement.” Prof. Kolvenbach is Chief of Vascular Surgery at Augusta Hospital of the Düsseldorf Catholic Hospital Group in Düsseldorf, Germany.
The company advised that the Enroute stent, which was developed pursuant to a license with Cordis Corporation, leverages the micromesh design and long-term durability of the Cordis Precise carotid stent that was studied in multiple clinical trials including SAPPHIRE, CASES-PMS, and SAPPHIRE Worldwide. The Enroute device has a shorter delivery system optimized for transcarotid access and was recently evaluated by leading European physicians.
The PMA was based in part on data collected from a subset (n = 52) of 141 high-surgical risk patients in the ROADSTER study who were treated with the Cordis Precise Pro RX stent system and the Enroute transcarotid NPS. The technical success rate was 100%, and the major adverse event rate at 30 days was 1.9%, consisting of a single minor stroke, which is comparable to the overall ROADSTER major adverse event rate of 3.5% and a 1.4% stroke rate, noted Silk Road Medical.