FDA expands indication to standard risk patients for transcarotid stent system
The FDA approved an expanded indication for a transcarotid stent system to include patients at standard risk for adverse events from carotid endarterectomy, according to a press release from Silk Road Medical.
Previously, the stent system (Enroute) was approved for use only in patients with anatomic or physiological criteria that put them at high risk for complications from more invasive surgical procedures.
“This is the first time in history that a stent-based approach has demonstrated noninferiority in stroke and death rates relative to CEA, with our transcarotid artery revascularization [TCAR] system offering the added benefit of significantly reduced cranial nerve injury risk,” Erica Rogers, president and CEO ofSilk Road Medical, said in the release. “This label expansion levels a playing field once dominated by open surgical techniques, allowing an expanded number of patients and physicians access to the benefits of a less invasive treatment option.”
As Healio previously reported, the Enroute device allows for a small surgical incision above the clavicle for direct carotid access and initiation of high flow reversal into a venous circuit with a filter to protect the brain from stroke while delivering and implanting the transcarotid stent.
Silk Road Medical previously submitted a PMA supplement, which included data extracted from the Vascular Quality Initiative. The surveillance data included in the submission represented real-world outcomes from 20,264 patients considered at standard surgical risk. Those data demonstrated that use of Silk Road Medical’s TCAR system is statistically noninferior in stroke and death outcomes to CEA, while showing a ninefold reduction in cranial nerve injury (2.7% vs. 0.3%; P < .001).
“Pairing the right patient with the right treatment results in significantly improved physician and patient experiences and outcomes,” Marc L. Schermerhorn, MD, chief of the division of vascular and endovascular surgery at Beth Israel Deaconess Medical Center and professor of surgery at Harvard Medical School, said in the release. “I speak for the vascular community in welcoming this label expansion for TCAR and recognizing this as a vital advancement in the treatment paradigm for patients at risk of stroke.”