The FDA has approved the NexStent Carotid and Monorial Delivery System for carotid artery disease patients who are at high risk for surgery — that approval taking Boston Scientific (Natick, Massachusetts) within 90 days of acquiring EndoTex Interventional Systems (Cupertino, California).

The NexStent Carotid Stent is manufactured by EndoTex and has been distributed exclusively by Boston Scientific outside the U.S. since it received the CE mark in 2005. Boston Scientific said it will acquire EndoTex within 90 days under the companies’ existing agreements.

EndoTex said that its FilterWire EZ Embolic Protection System, which was studied together with the NexStent Carotid Stent in the CABERNET clinical trial, is still pending 510(k) clearance by the FDA.

Paul Edwards, a spokesman for EndoTex, told Medical Device Daily that the approval of NexStent, the company’s core product, was a primary goal for EndoTex and key to moving the company closer to its acquisition by the big interventional technology company.

“This is Boston Scientific’s opportunity to go out into the U.S. market and talk about carotid stenting,” Edwards said. “We’re providing them with access to the U.S. market” in this particular sector.

The NexStent Carotid Stent is a laser-cut, nitinol stent with a rolled sheet design enabling one stent size to adapt to multiple diameters in tapered or non-tapered vessel configurations, according to the company. This “self-sizing” feature is designed to provide adaptability when treating lesions in the carotid arteries, and its closed-cell configuration is designed to increase lesion coverage and provide a smooth inner lumen to help facilitate delivery and retrieval of ancillary devices.

The NexStent Carotid Stent is intended “to provide a low profile option for physicians who want a high degree of flexibility and plaque stabilization,” the company said in a statement.

Joseph Tartaglia, president/CEO of EndoTex, said approval of the NexStent was based on results of the CABERNET trial.

Boston Scientific offers accessories for the stenting system, including the Sterling Monorail PTA Balloon Dilation Catheter, Thruway Peripheral Guide Wire, Amplatz Super Stiff Guide Wire, the Mach 1 Peripheral Guide Catheter, and Imager II Angiographic Catheter.

Since they are located on the sides of the neck, the carotids are the main conduit through which blood flows from heart to brain, and plaque formation in them can impede blood flow, increasing the risk of stroke. Until recently, the primary option for opening these vessels was carotid endarterectomy, a procedure involving a vertical incision in the neck and artery and removal of the plaque.

Carotid artery stenting, a less-invasive procedure, involves guiding a stent-bearing catheter to the carotids, at the site of the blockage, where it expands and forces the walls of the arteries open, restoring the blood flow.

“This is an innovative stenting system that interventionalists in the U.S. have been waiting for,” said Subbarao Myla, MD, of Hoag Memorial Hospital (Newport Beach, California) and co-principal investigator of the CABERNET trial. “Study results demonstrate excellent outcomes at one month — when there is the greatest risk of procedure-related stroke — through one year in patients with a wide range of lesions and vessel anatomy.”

Boston Scientific first invested in EndoTex in July 2001 and negotiated an exclusive option to buy the company, which makes less-invasive medical devices and specializes in carotid stent technology.

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