The latest research data on arterial thrombectomy in acute ischemic stroke

January 31, 2018 Source: WuXi PharmaTech

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Penumbra recently announced the results of the company's funded acute ischemic stroke arterial thrombectomy PROMISE study at the International Stroke Conference (ISC 2018) in Los Angeles. The study used A direct aspiration first pass technique (ADAPT) to treat acute ischemic stroke, demonstrating the safety of the Penumbra thrombectomy system using ACETM68 and ACETM64 reperfusion catheters as first-line therapy. And effectiveness.

At present, the number of deaths due to stroke in China has exceeded that of cancer and cardiovascular disease, making it the first cause of death. Acute ischemic stroke is the infarction of brain tissue caused by occlusion of cerebral arteries. It is the most common type of stroke, accounting for 60% to 80% of all stroke cases in China. Cerebral ischemia leads to rapid death of cells in the ischemic core region. Imaging and basic research over the past few decades have found that in a few hours after cerebral ischemia, a region between the core region and healthy brain tissue is treated in time. It may be saved, this area can be observed by imaging methods, known as "ischemic penumbra", English is Penumbra. This is also the reason for the name of Penumbra.

The Penumbra System® is a fully integrated system designed specifically for mechanical thrombectomy and was first approved by the US FDA in December 2007 for a 510(k) license. The Penumbra system acts on the proximal surface of the thrombus and gently draws the thrombus from the intracranial blood vessels through a suction platform for revascularization in patients with acute ischemic stroke with intracranial large vessel occlusion. The latest generation of Penumbra systems are equipped with ACETM reperfusion catheters, high flow pipettes, 3D revascularization devicesTM and MAXTM vacuum pumps and accessories. The ACE68 refill catheter introduced in 2016 has excellent traceability and is more attractive through its large flow of 0.068 inches inside diameter. The 3D revascularization device introduced in 2017 is specifically designed to work best with ACE reperfusion catheters.

â–²The ACE68 refill catheter introduced in 2016 has excellent traceability and is more attractive through its large flow of 0.068 inch inner diameter (Source: Penumbra official website)

The PROMISE study is a prospective, one-arm, multicenter study designed to evaluate the safety and efficacy of the Penumbra thrombectomy system using ACETM68 and ACETM64 reperfusion catheters. The study enrolled a total of 204 patients in 20 centers in Europe. The primary endpoints of the study included the revascularization rate (2b-3 points) of the mTICI score assessed by the independent core laboratory, and the clinical independence (0-2 points) measured by the modified Rankin score (mRS) at 90 days. The results showed that the revascularization rate reached 93.1%, and 39.2% of the patients achieved mTICI 3 grade revascularization. Clinical independence at 90 days reached 61%. Key secondary safety-related endpoints also showed excellent results: all-cause mortality was 7.5% at 90 days, symptomatic intracranial hemorrhage (sICH) was 2.9% at 24 hours, and 1.5% of new-onset (ENT) embolization. The median time to surgery, and the time from inguinal puncture to mTICI grade 2b-3 revascularization, was 31 minutes (20.0-53.0 minutes).

â–² Dr. Peter Schramm, Department of Neuroradiology, Schleswig-Holstein University, Germany (Source: Schleswig-Holstein University Official Website)

One of the main members of the study, Dr. Peter Schramm from the Department of Neuroradiology at Schleswig-Holstein University in Germany, reported the results. He said: "ADAPT as a first-line method has shown excellent results in revascularization rates and clinical outcomes. In addition, low mortality and strong safety have shown that the use of ACE68 and ACE64 to achieve revascularization after cerebral ischemia is safer and more effective than ever."

â–² Dr. Adam Elsesser, Chairman, CEO and President of Penumbra (Source: Penumbra Official Website)

Dr. Adam Elsesser, Chairman, CEO and President of Penumbra, said: "We are grateful to all PROMISE researchers for their important contribution to the growing global evidence for ADAPT as a first-line therapy for patients with acute ischemic stroke. The PROMISE study has strengthened our The belief that ACE68's Penumbra system provides a fast, safe and cost-effective method for revascularization of ischemic stroke."

We congratulate Penumbra for the excellent results and look forward to more safe and effective ways to alleviate the pain of stroke patients.

Reference materials:

[1] ADAPT Reperfusion with ACE64 and ACE68 Is Safe and Effective in Large Vessel

Occlusions of the Anterior Circulation – The PROMISE Registry Results

[2] Penumbra Shows Off Real-World Study Data in Acute Ischemic Stroke Trial

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