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
NTT DATA and ENGIE Announce Strategic Partnership to Power Sustainable AI and Data Center Growth29.7.2026 11:00:00 CEST | Press release
Multinational partnership to support sustainable expansion of NTT DATA’s global data center operations for AI, cloud and digital infrastructure growth.Long-term access to low-carbon and renewable energy with agreements already signed in UK, Germany and Netherlands.Power from RE100-compatible 24 MW wind farm in UK is already operational. NTT DATA, a global leader in AI, digital business and technology services, and ENGIE, a major player in the energy transition, today announced a strategic partnership to support the decarbonization, energy resilience and sustainable expansion of NTT DATA’s global data center operations. By combining ENGIE’s global leadership in renewable energy and low‑carbon solutions with NTT DATA’s infrastructure and technology services, the partnership secures long-term access to competitive renewable energy and power solutions that support the continued growth of NTT DATA’s data centers and AI infrastructure while addressing its net-zero ambitions. The partnership
Quectel Launches High-Performance FCM665D Module for Edge AI Applications29.7.2026 11:00:00 CEST | Press release
New high-performance module combines edge AI processing, Wi-Fi 6 and Bluetooth connectivity for smart home, smart building and industrial IoT applications Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announces the launch of the FCM665D, a high-performance Wi-Fi 6 and Bluetooth module with edge AI processing capabilities, designed for smart home, smart building and industrial IoT devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260729751874/en/ Quectel launches high-performance FCM665D module for edge AI applications Designed for products such as smart lighting, video doorbells and central control hubs, the FCM665D pairs high-performance connectivity with on-device intelligence, giving manufacturers a way to build faster, smarter, more capable devices without leaning on constant cloud connectivity. “This module has the AI capabilities and processing power to compete at the highest level
1NCE and Pessl Instruments Connect Smart Farms Worldwide29.7.2026 10:00:00 CEST | Press release
IoT specialists 1NCE and Pessl Instruments help farmers in 80 countries to connect and manage thousands of weather stations Smart farming solution improves water and fertilizer efficiency Both companies provide critical components at a 99.97% service availability 1NCE, a company offering a plug-and-play platform for creating and managing the world’s best IoT products, and Pessl Instruments, a global leader in smart agriculture, announce today the roll-out of the METOS by Pessl Instruments weather network solution powered by 1NCE. The smart farming solution provided by Pessl Instruments connects thousands of weather stations and field sensors through a single platform, providing farmers real-time data of precipitation and soil moisture, extreme weather forecasting and crop disease risk in more than 80 countries. The main challenge for the deployment of smart farming solutions is always providing good coverage in rural areas. Thanks to 1NCE’s global connectivity service available in more
Cognita Reply Named an OpenAI Advanced Partner to Accelerate Enterprise Adoption of Frontier AI29.7.2026 10:00:00 CEST | Press release
Cognita Reply, the Reply Group company specialising in OpenAI technologies, today announced that it has been named an OpenAI Advanced Partner within the OpenAI Partner Network. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260729234340/en/ Cognita Reply, the Reply Group company specialising in OpenAI technologies, today announced that it has been named an OpenAI Advanced Partner within the OpenAI Partner Network, to accelerate enterprise adoption of frontier AI The OpenAI Partner Network is a global programme for partners to build, sell and deliver AI solutions with OpenAI. It brings together partners with deep industry expertise, delivery capabilities and customer relationships, while equipping them with resources, enablement and support to help enterprises adopt OpenAI frontier models and products and turn them into measurable impact. We’re pleased to welcome Cognita Reply as an OpenAI Advanced Partner. The Cognita Reply
T964 Named as Uptime Institute Business Partner to Power Iraq’s Digital Infrastructure29.7.2026 09:02:00 CEST | Press release
Agreement signed at U.S.-Iraq Business Summit brings the world’s most trusted digital infrastructure standards to Iraq Uptime Institute and Tech964 Holding Limited (T964), Iraq’s leading digital infrastructure company, today announced a landmark strategic partnership to accelerate Iraq’s digital transformation. The partnership combines the world’s leading authority in digital infrastructure standards with the company building the critical infrastructure underpinning Iraq’s digital economy. The agreement was signed at the U.S. Chamber of Commerce U.S.-Iraq Business Summit on July 17, 2026, during the official U.S. visit of Iraqi Prime Minister Ali Al-Zaidi, at a historic summit that produced more than 50 agreements valued at over USD $60 billion and marked a powerful new era of economic cooperation between the United States and Iraq. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260728066813/en/ T964 named as Uptime Institut
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