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Mitigating Brain Injury during TAVR Procedures

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Protembis receives €20 million backing from the European Investment Bank

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Protembis receives €20 million backing from the European Investment Bank

Protection from Brain Injury and Stroke in TAVR

TAVR procedures can cause silent brain infarcts, which may lead to covert clinical stroke and an increased risk of future cognitive decline and dementia.

Technology behind
Protembis

The ProtEmbo® Cerebral Protection System (CPS) brings together best-in-class next generation design properties to protect the whole brain safely.

Clinical Evidence
Focus

94%

of patients treated with ProtEmbo are free of clinically meaningful brain lesions greater than 350mm³.

500

patients to be randomized in a landmark clinical trial using advanced DW-MRI imaging to demonstrate efficacy.

0%

ProtEmbo-related adverse events in all clinical studies to date.

Clinical Studies

Ongoing

The PROTEMBO IDE Study

Prospective, multi-center, randomized, controlled trial with the goal to compare the safety and efficacy of the ProtEmbo to a hybrid control (the Sentinel CEP and No Device) in TAVR patients.

11/23/2022

The PROTEMBO C Study

The study met its predefined safety and performance endpoints while demonstrating encouraging DW-MRI data: 94% of patients treated with ProtEmbo were free of clinically meaningful brain lesions.

02/19/2018

The PROTEMBO SF Study

Results of this study demonstrated that the ProtEmbo was safe and feasible to use. A trend to lower volumes of new cerebral lesions compared to comparison subjects was observed.

The Story behind
Protembis

Protembis was founded in 2013 and is headquartered in Aachen, Germany. The company develops innovative technologies to reduce the risk of new brain injury during cardiology procedures particularly in connection with transcatheter aortic valve replacement (TAVR).

Latest news and events

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Events 10-29-2024

Highlights from the Protembis Breakfast Symposium at TCT 2024

Protembis sponsored a satellite symposium at TCT 2024, uniting renowned co-chairs, expert speakers, and panelists to discuss key topics in cerebral protection for TAVR.
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News 07-30-2024

Protembis receives €20 million backing from the European Investment Bank

New financing for Protembis to accelerate ‘research and development’ programs, global ‘market access’ initiatives, and to complete the pivotal FDA clinical trial.
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News 04-02-2024

First Patient Enrolled in the PROTEMBO IDE Pivotal Trial

Only CEP trial designed as a superiority trial using DW-MRI to demonstrate effectiveness against the currently approved Sentinel device.
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News 03-26-2024

Protembis Completes €30M Financing and Adds Keith D. Dawkins to Board

Financing and Reinforcement of Board of Directors Builds Momentum in Readiness for the Initiation of the IDE Pivotal Trial.
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News 03-05-2024

European PROTEMBO C Trial Published in EuroIntervention Journal

New published European clinical evidence builds momentum for the FDA approved Pivotal PROTEMBO clinical trial.
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News 10-23-2023

FDA Approval of Pivotal Investigational Device Exemption (IDE) Study

Novel Adaptive Superiority Trial Design of ProtEmbo® Cerebral Embolic Protection (CEP) System.
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