CAPTIS · Project

Blood Filter Device Prevents Strokes During Heart Valve Replacement Surgery

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When doctors replace a worn-out heart valve through a catheter (a common procedure called TAVI), tiny bits of debris break loose and can travel to the brain, causing strokes in a shocking number of patients. Think of it like renovating old plumbing — chunks of buildup get knocked free and clog things downstream. The CAPTIS device works like a smart net placed inside the aorta that catches and removes those dangerous particles before they reach the brain or kidneys. Unlike the only competing device on the market, this one provides full-body protection and slides in through the same access point as the valve itself, so there is no extra puncture needed.

By the numbers

20 million

People affected by aortic stenosis worldwide

70%

TAVI patients developing new ischemic brain lesions post-procedure

Major disabling strokes in TAVI patients

12.3%

Kidney dysfunction rate in TAVI patients

EUR 2,135,000

EU contribution for clinical validation and CE mark

The business problem

What needed solving

Every year, thousands of patients undergoing heart valve replacement through TAVI suffer strokes and organ damage because debris breaks loose during the procedure and travels through the bloodstream. Current protection devices only partially shield the brain, require an extra puncture site, and slow down the surgery. Hospitals and insurers face massive costs from these preventable complications.

The solution

What was built

Filterlex built CAPTIS, a catheter-based embolic protection device that deflects, captures, and removes debris particles during TAVI heart valve replacement. The project focused on validating safety and efficacy through First-In-Human and multi-site clinical trials, with the goal of obtaining CE mark certification for European commercialization.

Audience

Who needs this

Cardiovascular medical device distributors seeking differentiated cardiology productsInterventional cardiology centers performing high volumes of TAVI proceduresHealth insurers looking to reduce post-TAVI complication costsMedical device companies seeking licensing or co-marketing partnerships in structural heartHospital procurement teams evaluating embolic protection solutions

Business applications

Who can put this to work

Medical Device Distribution

mid-size

Target: Cardiovascular medical device distributors and importers

If you are a medical device distributor covering European or Middle Eastern markets and looking for next-generation cardiology products — this project developed CAPTIS, a catheter-based embolic protection device that provides full-body protection during TAVI procedures. With embolic debris causing new brain lesions in 70% of TAVI patients, hospitals are actively seeking better protection devices. Only one competing EPD exists on the market today, creating a clear gap for distributors to fill.

Hospital Cardiology Departments

enterprise

Target: Interventional cardiology centers performing TAVI procedures

If you are a hospital or cardiac surgery center performing TAVI procedures and losing patients to post-operative stroke — this project built a device that captures embolic debris released during valve replacement without requiring a secondary artery access. Current solutions provide only partial cerebral protection and add procedure time. CAPTIS aims to reduce the 9% rate of major disabling strokes and 12.3% kidney dysfunction seen in TAVI patients today.

Health Insurance & Managed Care

enterprise

Target: Health insurers and reimbursement bodies covering cardiac procedures

If you are a health insurer dealing with the enormous cost of post-TAVI stroke care and extended hospital stays — this project developed a device targeting the root cause of those complications. With 20 million people worldwide affected by aortic stenosis and TAVI volumes growing, reducing the 70% rate of new ischemic brain lesions post-procedure could significantly cut downstream treatment costs and long-term disability claims.

Frequently asked

Quick answers

What does the CAPTIS device cost and how is it priced?

Pricing information is not disclosed in the available project data. As a single-use catheter-based medical device competing with one existing EPD on the market, pricing would likely be positioned relative to that competitor and the cost savings from preventing post-TAVI strokes. Contact the manufacturer for commercial pricing.

Can this scale to high-volume TAVI centers?

The device is designed for use through the same artery access as the TAVI system itself, eliminating the need for secondary access. This simpler setup reduces procedure time compared to the existing competing device, which suggests it could integrate into high-volume workflows more easily. The project planned multi-site clinical trials to validate performance across different hospital settings.

What is the IP and licensing situation?

CAPTIS is developed by Filterlex Medical Ltd, an Israeli SME that holds the product rights. The project received EUR 2,135,000 in EU SME Instrument Phase 2 funding, which typically supports companies bringing their own IP to market. Licensing or distribution inquiries should be directed to Filterlex Medical.

What regulatory approvals does CAPTIS have?

The project objective states that CE mark certification for European commercialization was a key goal. The project also planned First-In-Human and multi-site clinical trials during the 2019-2021 funding period. Based on available project data, the current regulatory status should be confirmed directly with Filterlex Medical.

How does CAPTIS compare to existing embolic protection devices?

According to the project data, only one EPD has been commercialized for TAVI to date, and it provides only partial cerebral protection, requires secondary artery access, and interferes with the TAVI delivery system. CAPTIS is designed to provide full-body protection through the same TAVI artery access, avoiding these limitations.

What clinical evidence supports this device?

The project planned a First-In-Human clinical trial followed by a multi-site clinical trial during the 2019-2021 period. The project is now closed. Based on available project data, current clinical evidence status should be confirmed with the manufacturer at filterlex.com.

Consortium

Who built it

This is a single-company project by Filterlex Medical Ltd, an Israeli SME that received the full EUR 2,135,000 through the EU's competitive SME Instrument Phase 2 program. The 100% industry composition with no academic partners signals a commercially mature venture — the science is done, and the focus is on clinical validation and market entry. The fact that an Israeli company secured EU funding specifically for CE mark certification shows clear intent to enter the European medical device market. For potential business partners, this means you would be dealing directly with the device manufacturer, not navigating a complex academic consortium.

FILTERLEX MEDICAL LTDCoordinator · IL

How to reach the team

Filterlex Medical Ltd (Israel) — contact via filterlex.com or through SciTransfer for a facilitated introduction

Order a report on this consortium See FILTERLEX MEDICAL LTD profile →

Next steps

Talk to the team behind this work.

Want to explore distribution, licensing, or clinical partnership opportunities with CAPTIS? SciTransfer can arrange a direct introduction to the Filterlex Medical team and provide a detailed technology brief.

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