Covidien has released the results of its STAR study (Solitaire™ FR Thrombectomy for Acute Revascularization). The two-year study evaluated the safety and efficacy of the Solitaire FR revascularization device in the treatment of acute ischemic stroke.
Covidien’s Solitaire FR device is designed to restore blood flow in patients experiencing ischemic stroke, a condition estimated to cost the U.S. economy $39Bn in 2008. Solitaire is based on advanced overlapping stent technology and is designed mechanically remove blood clots from blocked large intracranial vessels in patients experiencing ischemic stroke within eight hours of symptom onset.
Specifically it is designed for mechanical blood clot removal in the neurovasculature, including the internal carotid artery, M1 and M2 segments of the middle cerebral artery, Basilar and vertebral arteries.
STAR is a prospective, multi-centre, single arm clinical study. With an enrollment of 202 patients at 14 centres across Europe, Australia and Canada in May 2010, the last patient completed participation in October 2012.
In the study, patients diagnosed with AIS (as confirmed by radiographic assessment) were treated with the Solitaire FR device in order to reopen, or recanalize, the blocked blood vessels. The results indicated that 84.2% (160/190) of patients with complete angiographic data sets and 79.2% (160/202) of patients with missing angiographic data, as determined by an independent Core Lab, achieved the highest degree of recanalization (TICI 2b/3).
Long-term follow-up was obtained at 90 days to evaluate neurological health. Using the Modified Rankin Score (mRS), 57.9% achieved a score of 2 or less, indicating functional independence, with little to no disability. In addition, an independent Clinical Events Committee reported a 6.9% (14/202) mortality rate and a 1.5% (3/202) symptomatic intracranial hemorrhage rate.
The results indicate that treatment with the Solitaire FR device in intracranial anterior circulation occlusions is associated with a low risk of clinically relevant procedural and device-related complications, high rates of revascularisation , good Clinical Outcomes and Low mortality at 90 days.
The data also support the further investigation of the Solitaire FR device in a Randomized Controlled Trial against best medical treatment.
“The findings of the STAR study reflect the recent advances in stroke treatment,” said Jan Gralla, MD, MSc, STAR Principal Investigator, Department of Diagnostic and Interventional Neuroradiology, Inselspital, University of Berne, Switzerland. “In highly specialized stroke centers, endovascular treatment using novel stent retriever technology results in high rates of good functional outcome and low morbidity.”
“In the wake of the failed IMS III Study, a NINDS-funded randomized controlled trial, there will be some physicians who will question the benefit of mechanical thrombectomy,” said Vitor Mendes Pereira, M.D., MSc, STAR Principal Investigator, Head of Interventional Neuroradiology, University Hospital of Geneva, Switzerland. “The results of the STAR prospective, multi-center clinical study demonstrate that mechanical thrombectomy is both safe and effective for the treatment of acute ischemic stroke when treating the right patients, in comprehensive stroke centers, with the Solitaire FR device.”
“We are pleased to report that the STAR study adds to the growing body of evidence supporting the use of the Solitaire FR device as a superior tool for revascularization in acute ischemic stroke care,” said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “Given the medical and economic burden of AIS to patients and healthcare systems, there is an urgent need to develop innovative solutions for the timely, safe and effective treatment of acute ischemic stroke. The Solitaire FR device represents new hope in addressing this widespread public health issue.”
The Solitaire FR received CE Mark approval in 2009 and U.S. Food and Drug Administration 510(k) clearance in 2012.