Positive results in trial of Solitaire (Covidien) for blood flow restoration

The Solitaire Flow Restoration Device for opening blocked arteries, from Covidien, performs better than a conventional device, according to new results from the SWIFT trial which have been published in The Lancet.

In the double-blind, randomised trial of 113 patients, the researchers compared the performance of the Solitaire device to the Merci retriever. Patient outcomes were significantly improved in the group who had been treated with the Solitaire device, with 58% being assessed as having a good neurological outcome after three months, compared to 33% of those treated with the Merci retriever; patient deaths were also reduced, from 38% with Merci to 17% with Solitaire. The Solitaire device is significantly better at restoring blood flow (reperfusion) in affected arteries when compared to the Merci device.

Solitaire is a self-expanding stent made with thin wires. Once inside, it traps the clot and is pulled out through the catheter, reopening the blocked blood vessel. Solitaire was approved by the FDA in March 2012, and is approved in the EU.

Due to the positive results seen in SWIFT, the safety committee overseeing the trial recommended it stop early. According to lead author Jeffrey L. Saver, director of the University of California - Los Angeles (UCLA) Stroke Center, "This new device is significantly changing the way we can treat ischemic stroke." See: "Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial" Jeffrey L Saver et al. The Lancet, August 26, 2012 http://dx.doi.org/10.1016/S0140-6736(12)61384-1