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| Silk Road Medical's Enroute Transcarotid Neuroprotection system--Courtesy of Silk Road Medical |
Sunnyvale, CA's Silk Road Medical announced CE mark approval of a second-gen iteration of its Enroute Transcarotid Neuroprotection System for the treatment of blocked carotid arteries in the neck that could cause stroke.
The company last year earned FDA clearance for the original Enroute NPS, which enables the insertion of a stent into the artery in the neck, instead of through the groin and up the leg's femoral artery, reducing surgical risks and potential complications associated with more invasive procedures. The procedure is known transcarotid artery revascularization. The FDA approved the transcarotid stent in May.
In addition to transcarotid (through the neck) access, the procedure protects the brain during the intervention via what's known as flow reversal. The mechanism redirects blood flow away from the brain so that it can carry any debris created by the procedure to an external filter. Traditionally an internal filter is placed between the lesion and the brain to catch the debris, Silk Road says on its website.
"We have been working to improve the safety profile of carotid revascularization through the development of the TCAR procedure, and this latest design of the Enroute NPS for TCAR is state-of-the-art," said Dr. Antonio Orgaz, Chief of Vascular Surgery at Virgen de la Salud Hospital in Toledo, Spain, in a statement. "We were extremely impressed with the smooth, atraumatic entry of the sheath into the carotid artery and the more ergonomic design of the overall system. It is easy to use and inspires confidence."
In October, Silk Road announced a $57 million debt and equity financing featuring CRG and returning investors Warburg Pincus and The Vertical Group. The company said it plans to use the latest round of financing to continue commercialization neuroprotection system in the U.S., build out evidence in support of TCAR procedures and begin.
"Whereas elsewhere in the body we routinely use minimally invasive endovascular techniques to treat vascular disorders, carotid artery disease is one of the last frontiers that is still treated primarily by an invasive surgical approach," said Professor Ralf Kolvenbach, director, of the department of vascular surgery and endovascular therapy at Augusta Krankenhaus hospital in Düsseldorf, Germany. "This is because techniques used during carotid surgery are very good at protecting the brain during the procedure. With the Enroute NPS we can leverage surgical principles of neuroprotection like avoiding unprotected maneuvers, maintaining exquisite control of the carotid bifurcation and blood flow, and removing embolic fragments of any size. But we can now do it in a less invasive manner that mitigates the risks of surgical complications like cranial nerve injury and wound complications while providing the patient with an aesthetic result and a quicker recovery."
- read the release