FDA approval for new clot removal device

Published date : 15 August 2012
Article date : 14 August 2012

Stryker Neurovascular's Trevo Pro Retriever has been granted market clearance by the FDA. The device, launched in Europe in 2010, uses the manufacturer's Stentriever technology for optimised clot integration and retrieval in patients experiencing acute ischemic stroke.

Earlier this year, results of the Thrombectomy REvascularisation of large Vessel Occlusions in acute ischemic stroke study were presented at the International Stroke Conference. 60 patients were enrolled by 7 leading European stroke centers. The study assessed the ability of the Trevo system to remove the blood clots that cause strokes and to restore blood flow to the brain.

Revascularisation, measured by an independent lab, showed high rates in 91.7% of patients. 46% achieved a good outcome in 7 days and at 90 days, the good outcomes rate increased to 55%. Furthermore, the patients with good outcomes were functionally independent (modified Rankin score of 2 or less). A low symptomatic intracranial hemorrhage rate of 5% was also reported.

The Trevo Pro Retriever also demonstrated strong clinical results in the TREVO 2 clinical trial presented at the European Stroke conference in May, this year. 

Source: Amanda Pedersen, Medical Device Daily Senior Staff Writer, Medical Device Daily, 14 August 2012

Read the full article here

Back to Listings

WhichMedicalDevice is a FREE resource created by clinicians for clinicians.

Registration is free and gives you unlimited access to all of the content and features of this website.

Find out more...

Please sign in to view this content...

I have forgotten my password
Not a Member?

Registration is free and gives you unlimited access to all of the content and features of Which Medical Device. Find out more...

Why Register

Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis. We ask that our members register with us so that we can maintain the unbiased and independent nature of our content. Registration is quick and free.

We do not make your details available to any third parties nor do we send unsolicited emails to our members. You can read our Privacy Policy here.