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June 1, 2022

Filterlex Medical reports positive data from CAPTIS device study

The device deflects, captures and removes embolic particles while providing full-body embolic protection.

Cardiovascular medical device startup Filterlex Medical has reported positive data from its CAPTIS full-body embolic protection device in a first-in-human (FIH) study.

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The next-generation CAPTIS device is designed to lower the risk of stroke as well as other problems during left-heart procedures. It can be deployed and retrieved easily and intuitively.

With a distinctive, triple-action design, the device deflects, captures and removes embolic particles while providing full-body embolic protection.

The device is implanted in the aorta, preserving its surface while allowing a smooth Transcatheter Aortic Valve Replacement (TAVR) procedure. It needs no extra access and does not disrupt the procedure workflow.

Using the CAPTIS embolic protection device, 20 patients underwent a successful TAVR procedure in the prospective, single-arm study.

The findings demonstrated that the device was deployed and retrieved successfully in all patients. Furthermore, the procedure was performed without any disruption.

Filterlex Medical co-founder and CEO Sigal Eli said: “We are extremely encouraged by the study and will continue to build robust clinical evidence around the CAPTIS embolic protection device to support its use in TAVR.”

The company noted that there were no device-related complications and that patients did not experience cerebrovascular events.

The European Union’s Horizon 2020 research and innovation programme provided funding for the project.

Wolfson Medical Center Interventional Cardiology head and study principal investigator Haim Danenberg said: “Safe and effective brain protection in percutaneous heart procedures is a true unmet need – I am very impressed with the promising CAPTIS technology. Filterlex has developed an innovative solution that protects TAVR patients’ brain and kidneys.”

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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