The Massachusetts-based medical device giant enrolled its 1st patient in the MAJESTIC clinical trial of its Innova peripheral vascular drug-eluting stent for treatment of blocked arteries above the knee.
The Innova line is Boston Scientific’s 1st peripheral drug-eluting stent system, featuring a proprietary drug-polymer combination that the company says will "facilitate optimal release of the drug and prevent restenosis (narrowing) of the vessel."
In total the MAJESTIC trial will enroll 55 patients at 15 centers in Europe, New Zealand and Australia, according to the press release. The device has investigational approval from the FDA and is not cleared for sale in the U.S.
Boston Scientific has also developed a bare-metal version of the Innova stents, and the company earlier this year enrolled the last of 299 patients in the SuperNOVA clinical trial evaluating the device.
In a separate announcement, Boston Scientific this week released positive findings from the Re-ROUTE clinical study of its OffRoad re-entry catheter system for treatment of blockages in the arteries that supply blood to the legs. The device is comprised of a balloon catheter with a micro-catheter lancet, designed to route past complete arterial blockages by traveling through the vessel wall.
The company reported an better-than-expected 84.8% success rate in enrolling patients, using the OffRoad device to navigate around complex and challenging chronic total occlusions. After 1 month 75% of enrolled patients experienced improvements in symptoms associated with peripheral artery disease, according to the statement, and investigators reported a 3.3% major adverse event rate, lower than had been anticipated.
The OffRoad system has CE Mark approval for sale in the European Union and is pending 510(k) clearance for the U.S. market. Boston Scientific acquired the OffRoad technology when it nabbed Minnesota-based BridgePoint Medical last year for an undisclosed amount.