Covidien commits to advance clinical research in clot retrieval technology

Covidien, a leading global provider of healthcare products, recently brought together six of the world’s prominent thought-leaders in stroke at the 2013 European Stroke Conference (ESC). At a Covidien-sponsored symposium, the stroke experts presented and discussed data underscoring the benefits of endovascular therapy in treating acute ischemic stroke and, particularly, the important role that new devices play when this procedure is performed to remove blood clots from large vessels in the brain.

“Shorter time from onset of symptoms to restoration of blood flow and degree of reperfusion were crucial elements necessary to achieve better outcomes for patients with endovascular treatment in the IMS-III trial,” said Andrew Demchuk, MD, Director of the Calgary Stroke Program and Associate Professor in the Department of Clinical Neurosciences and Radiology at the University of Calgary’s Foothills Medical Centre. “This bodes very well for new endovascular devices, such as the Solitaire FR revascularization device, where short procedure times and high rates of reperfusion have been seen in recent studies. There is a very bright future for endovascular devices in the acute treatment of stroke. It is absolutely essential we focus attention on reducing all delays in our health system structure to dramatically reduce the time between symptom onset and therapeutic intervention.”

The panel at the Covidien symposium included principal investigators from Covidien’s randomized controlled trial, SWIFT Prime, as well as from three other trials investigating mechanical thrombectomy with the Solitaire FR device: ESCAPE, EXTEND-IA and REVASCAT. These investigators are:

SWIFT Prime: Prof. Jeff Saver, MD, Professor of Neurology at the David Geffen School of Medicine and Director of the UCLA Stroke Center, University of California, Los Angeles, USA
ESCAPE: Associate Prof. Andrew Demchuk, MD, Calgary, Canada
EXTEND-IA: Bruce Campbell, MD, Neurologist and Research Fellow, Royal Melbourne Hospital, Australia
REVASCAT: Prof. Antony Davalos, MD, Head of the Department of Neurosciences, Hospital Universitary Germans Trias i Pujol, Barcelona, Spain

Prof. Davalos also presented data from the STAR trial, which proved the Solitaire FR device as a safe and effective treatment in stroke patients with a large vessel anterior occlusion.

“Recent innovations in mechanical thrombectomy technology have led to improved outcomes, compared to first-generation devices designed to remove large blood clots in acute stroke patients,” commented panel moderator Patrik Michel, MD, Secretary General of the European Stroke Organisation and Chief of the Stroke Center at Centre Hospitalier Universitaire de Lausanne in Switzerland. “Prompt treatment with intravenous and endovascular approaches seems to be of paramount importance. Modern clot retrieval devices open a window to potentially treat patients well after the 4.5-hour window for intravenous tissue plasminogen activator (IV tPA), but this needs to be proven in future randomized trials.”

According to the results of the 144-patient SWIFT study, the Solitaire FR device achieved substantially better safety and clinical outcomes than the Concentric Medical Merci Retriever™ device, a first-generation clot retrieval systemi that was used in a significant majority of patients enrolled in the device arm of the large IMS-III study.ii

“Covidien is committed to answering the question of the effectiveness of mechanical thrombectomy over current treatments,” said Brett Wall, President, Neurovascular, Covidien. “These studies reflect the recent advances in stroke treatment, adding to the growing body of scientific evidence that shows mechanical thrombectomy to be safe and effective in treating acute ischemic stroke with the Solitaire FR device.”

i Saver JL, Jahan R, Levy EI, et al. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012;380(9849):1241-9.

ii Broderick JP, Palesch YY, Demchuk AM, et al. Endovascular therapy after intravenous t-PA versus t-PA alone for stroke. N Engl J Med. 2013;368(10):893-903.