New Clot Removal Devices Effective in Stroke Patients, But Don't Trump Standard Care

Though two new blood clot removal devices only recently received FDA approval for clinical use, specialists at the Stony Brook University Cerebrovascular and Stroke Center have already seen improved outcomes in acute ischemic stroke patients after performing endovascular treatments with both advanced technologies.

Though two new blood clot removal devices only recently received FDA approval for clinical use, specialists at the Stony Brook University Cerebrovascular and Stroke Center have already seen improved outcomes in acute ischemic stroke patients after performing endovascular treatments with both advanced technologies.

“In acute ischemic stroke, ‘time is brain,’ and in some cases, just minutes matter. Therefore, restoring blood flow in an effective and timely manner is critical to the survival and recovery of stroke patients,” David Fiorella, MD, Phd, a professor of clinical neurological surgery and radiology at Stony Brook’s School of Medicine, said in a news release.

Respectively granted market clearance by the FDA in March 2012 and August 2012, Covidien’s Solitaire Flow Restoration revascularization device and Stryker Neurovascular’s Trevo ProVue stent retriever device are both intended to remove blood vessel clots from stroke victims’ brains via microcatheter and restore blood flow in the neurovasculature while preserving brain cells.

Though two separate clinical trials funded by Covidien and Stryker and reported in the October 6, 2012, edition of The Lancet concluded that both Trevo and Solitaire achieve better angiographic and neurological outcomes in acute ischemic stoke patients than their predecessor — the Merci Retrieval System — a study published online last month in the New England Journal of Medicine found mechanical procedures to remove blood clots were no more effective than standard, non-invasive care.

While Fiorella said in the news release clot-busting drugs are still standard in stroke treatment, he noted “in many more of the severe stroke cases where the main arteries of the brain are blocked, intravenous medications are predictably ineffective,” and after performing roughly 30 procedures on stroke patients with the second-generation instruments, he said both devices “enable us to quickly restore blood flow and retrieve the clot in most patients.”

“Many patients are not eligible for intravenous clot-busting medication because of their time of presentation, existing medical conditions, recent surgery or the medications they take, such as blood thinners,” Fiorella explained in the release. “In these cases where intravenous medications are ineffective or contraindicated, endovascular treatments using these new devices offer patients the most promise.”

Abstract of Solitaire Flow Restoration Device study in The Lancet

Abstract of Trevo Retriever study in The Lancet

Abstract of mechanical procedures study in NEJM