PROTEMBIS-GMBH
25.2.2021 06:17:10 CET | Business Wire | Press release
Protembis GmbH , a privately held emerging medical device company, announced today the successful completion of 20 clinical cases in its European regulatory study of the ProtEmbo® Cerebral Protection System. The ProtEmbo® System is an intra-aortic filter device that deflects embolic material away from the brain during transcatheter aortic valve replacement (TAVR). The device is a low profile system which is delivered through the left radial artery, an ideal access site enabling physicians to avoid interference with TAVR equipment, typically delivered through the left femoral artery.
Nikos Werner, M.D. , Professor of Medicine, Head of Cardiology at the Heart Center Trier, Germany, and Principal Investigator in Germany commented: “Embolic protection in TAVR procedures has been shown to be effective in reducing the ischemic burden in the brain, but physicians look forward to next generation devices that are easy to use, cover all three potential access arteries to the brain, and can be simply and rapidly deployed without interfering with the TAVR procedure. The initial procedures with the ProtEmbo® System are very promising in this regard and show that the device can fulfil all of these criteria, with even smaller pores allowing effective protection of the brain.”
This new generation of the ProtEmbo® System has an improved frame shape and a dedicated ergonomic handle to facilitate push-pull and torque of the device during deployment and retrieval. The filter, using 60 micron pores, is self-positioning in the aortic arch across all three major cerebral arteries, maintaining blood flow to the brain. The filter surface is heparin-coated to avoid clot formation.
Dariusz Jagielak, M.D. , Professor of Medicine, and his team at Medical University of Gdansk, Poland, have performed more than ten procedures with the device. He commented: “Recently, we presented the very first-in-human case at the PCR Valves e-Course in which the ProtEmbo® System was able to protect all three cerebral vessels from debris migration in a challenging TAVR procedure. Using the ProtEmbo® System is very intuitive because it is self-positioning across all three cerebral vessels and does not interfere with TAVR devices and accessories used during the procedure.”
Eberhard Grube, M.D. , Professor of Medicine, Head of Center of Innovative Interventions in Cardiology at University Hospital Bonn, Germany, Consulting Professor at Stanford University School of Medicine and Clinical Advisor to Protembis, commented: “The ProtEmbo® System has shown to be intuitively designed for seamless integration into the TAVR workflow. I am excited about this device because it offers a simple and elegant solution for reducing the risk of stroke during TAVR.”
Co-CEOs of Protembis, Conrad Rasmus and Karl von Mangoldt, are pleased with the progress of the study and commented: “We believe that the full coverage cerebral protection of the ProtEmbo® System from even extremely small particles in combination with outstanding simplicity enabling rapid and easy deployment will offer physicians significant advantages over existing technologies."
The objective of the European trial (PROTEMBO C Trial, NCT04618718 ) is to assess the safety and performance of the ProtEmbo® System used for embolic protection during TAVR compared to historical data. The trial is designed as a multi-center, single-arm study in 60 patients with severe symptomatic native aortic valve stenosis indicated for TAVR. Patients will undergo MRI assessments to evaluate the efficacy of the ProtEmbo® System.
About Protembis
Protembis is a privately-held, emerging medical device company that has developed the ProtEmbo® Cerebral Protection System. The company strives to offer a simple and reliable solution to protect patients from brain injury during left-sided heart procedures, improving patient quality of life and reducing overall healthcare costs associated with brain injury during those procedures. The ProtEmbo® System is available for investigational use only and is not approved for sale.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210224005838/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Go Beyond the Guidebook: Why Ireland Rewards Those Who Slow Down6.5.2026 18:15:00 CEST | Press release
In a world where travel often feels rushed and driven by checklists, Ireland stands apart. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260501313521/en/ Lusty Beg Island Kesh, Co. Fermanagh The destination offers something deeper, drawing visitors beyond the expected toward richer encounters with its landscapes, culture and communities. As a compact island, Ireland gives holiday makers the chance to take in much of the destination while still travelling at a relaxed, unhurried pace. It’s a chance to slow down, not to do less, but to feel more - more calm, more connection, and more of what makes travel meaningful. This approach to travel is matched by Ireland’s natural warmth and welcome, helping visitors feel at home from the moment they arrive. Take the scenic route From the rugged coastline of the Wild Atlantic Way, one of the world’s longest coastal routes, to the rolling landscapes of Ireland’s Hidden Heartlands, Irela
TACTICA AI Introduces Region’s First AI Platform for Mission-Critical, Real-Time Operational Decisions6.5.2026 17:18:00 CEST | Press release
Built on deep tech developed by TII, TACTICA AI moves beyond dashboards to help decision-makers turn fragmented intelligence, sensor, and operational data into action Showcased during Make it in the Emirates 2026, the platform has already been validated through real-world deployments in mission-critical environments Built in Abu Dhabi, connected globally, TACTICA AI integrates partnerships with French-based Safran and Polish-based Satim TACTICA AI, an Abu Dhabi-based start-up, today introduced its multi-domain decision-support platform to a wider market during Make it in the Emirates 2026. At a time of increasing operational complexity and pressure to make faster, better-informed decisions, the platform is designed to transform fragmented intelligence, sensor, and operational data into real-time decisions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260506006177/en/ TACTICA AI Introduces Region’s First AI Platform for Mis
FlightSafety International Receives FAA Approval for Virtual Aircraft Preflight Inspection with Evaluation Mode6.5.2026 16:05:00 CEST | Press release
Three aircraft programs approved, with three more expected to receive approval in 2026 FlightSafety International Inc., the global leader in aviation training and simulation technology, today announced it has received Federal Aviation Administration (FAA) approval for Virtual Aircraft Preflight Inspection (VAPI) with Evaluation Mode for three aircraft training programs: the Embraer EMB-550, Gulfstream G500/G600, and Citation Latitude. This innovative capability allows pilots in initial training to complete a 3D virtual aircraft preflight inspection while in Training Mode, with the added ability to transition directly into the flight deck, followed by Evaluation Mode, that allows pilots to do their preflight check ride portion. “VAPI represents a meaningful advancement in training innovation,” said David Penney, VP of Safety, Courseware and Regulatory Affairs, FlightSafety International. “By leveraging an immersive 3D environment, it offers pilots a more engaging and practical way to de
Riskified Unveils Next-Generation AI Suite at Ascend 2026, Empowering Merchants with Unprecedented Visibility and Control Over Ecommerce Risk6.5.2026 15:00:00 CEST | Press release
New capabilities include Riskified ARIA the AI Risk Analyst, Identity Explore 2.0, and an enhanced Decision Studio, giving merchants the power to see, understand, and act on network risk intelligence like never before Riskified (NYSE: RSKD), a global leader in ecommerce fraud and risk intelligence, today announced a major leap forward in its AI platform capabilities, introducing a powerful suite of control and empowerment tools designed to give merchant fraud teams complete visibility into risk patterns and identity behavior, conversational AI-driven insights, and the ability to surgically tailor their risk strategies. The innovation suite was announced onstage at Ascend 2026, Riskified’s premier global summit series, taking place May 4-6, 2026, at the Conrad New York Downtown in Manhattan, NY. With global ecommerce continuing to expand and losses from AI-driven fraud attacks projected to spike, particularly with the rise of agentic commerce, where AI bots may conduct transactions on b
Twilio’s Next Generation Platform: An Infrastructure Layer for Every Conversation in the Agentic Era6.5.2026 15:00:00 CEST | Press release
New platform capabilities orchestrate context-rich conversations with persistent memory across multiple channels for humans and AI agentsConversation Memory, Conversation Orchestrator, Conversation Intelligence, and Agent Connect provide the nervous system for modern customer engagement Twilio (NYSE: TWLO), the infrastructure for customer engagement in the AI era, kicked off its user conference, SIGNAL, by unveiling its next generation platform capabilities for the agentic era. Generally available today, Conversation Memory, Conversation Orchestrator, Conversation Intelligence, and Agent Connect combine to turn disparate interactions into continuous, intelligent, and personal conversations across humans, agents, and systems. “The agentic era is here. Agents are joining conversations alongside the people they represent, and modern customer engagement requires an infrastructure that serves both equally,” said Khozema Shipchandler, Chief Executive Officer at Twilio. “Twilio’s new platform
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom