Covidien plc (NYSE:COV) will take its Solitaire FR revascularization device directly to regulators rather than wait for additional clinical data, after an independent panel’s review of the data collected so far.
The Solitaire FR With the Intention For Thrombectomy (SWIFT) study began recruiting ischemic stroke patients in March 2010, intending to measure the safety and efficacy of the investigational device compared to results demonstrated by patients treated with a thrombectomy product already on the market and sold by Concentric Medical. Participants in the SWIFT study were to be measured at 30- and 90-day intervals after blocked arteries in the brain were re-canaled and the clots removed.
Solitaire FR received a CE Mark in July 2009, allowing for European sales, and Covidien is hoping to gain regulatory approval in the U.S. for doctors to use the device to restore blood flow in patients during the first eight hours after suffering a stroke. The Mansfield, Mass.-based medical products conglomerate acquired Solitaire FR as part of its $2.6 billion purchase last year of ev3 Inc.
The company decided to stop enrolling new patients for the current study after conferring with members of a Data Safety Monitoring Board, a panel of independent experts that recommended that the company take the trial data to the FDA now, rather than wait for all 200 of the proposed participants in the study to be treated and tested. Company officials did not disclose how many patients have been treated so far, or report any of the results, although they said Covidien now expects “moving forward with the 510(k) process … once the FDA has completed its review of the data,” according to securities documents filed Monday.
The company will continue follow-up care with patients already enrolled in the trial.