Dive Brief:

• Penumbra said Tuesday it has started a clinical trial that could support wider use of mechanical thrombectomy in a subset of stroke patients.
• The real-world prospective study is assessing Penumbra’s RED reperfusion catheter portfolio in patients with M2 occlusions.
• Penumbra, which Boston Scientific has agreed to buy for $14.5 billion, is assessing whether its computer-assisted vacuum thrombectomy and modulated aspiration tools improve outcomes.

Dive Insight:

M2 is a segment of the middle cerebral artery in the brain. Blockages of the segment affect about 3% to 7% of acute ischemic stroke patients, Penumbra said. The rate equates to about 21,000 to 66,000 M2 strokes annually. 

Last year, a study of Medtronic’s Solitaire intracranial stent-retriever devices found that endovascular treatment of medium-vessel occlusions, including M2 blockages, was no better than usual care. The trial was one of three studies published last year that found endovascular treatment failed to improve outcomes in patients with medium-vessel occlusions.

The clinical setbacks led some physicians to question whether healthcare professionals should stop the endovascular treatment of M2 occlusions. Penumbra’s existing evidence covers large-vessel occlusions, leading the company to launch a new study to show how its devices perform in medium M2 blockages.  

“The results of this study will help inform physicians on treatment selection for stroke patients with M2 occlusions, potentially supporting wider adoption of mechanical thrombectomy for this challenging condition,” Alex Spiotta, chief of the neurosurgery department and director of neuroendovascular surgery at the Medical University of South Carolina, said in a statement.

Spiotta is co-principal investigator for Penumbra’s trial.

The study will enroll up to 250 people at about 40 sites. Some patients will receive medical management and treatment with Penumbra’s RED reperfusion catheter portfolio, including its Thunderbolt computer assisted vacuum thrombectomy device. Other patients will only receive medical management.

Regulators in the U.S. and European Union recently authorized Thunderbolt to deliver modulated aspiration for acute ischemic stroke. The device reduces friction between the clot and the reperfusion catheter to cut the time it takes to remove clots and restore blood flow.