Protembis Announces First Patient Enrolled in the PROTEMBO IDE Pivotal Trial
Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the enrollment of the first patient in the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816). The trial will enroll between 250-500 randomized patients undergoing transcatheter aortic valve replacement (TAVR) in the USA and Europe with the ProtEmbo® System, an innovative next generation cerebral embolic protection device (CEP) providing complete 3-vessel coverage of the cerebral arteries. The PROTEMBO study aims to show superiority of the ProtEmbo® System against a hybrid control group: half receiving no CEP and half receiving the Sentinel™ CEP (Boston Scientific, Marlborough, MA, USA), which covers just two of the three cerebral arteries that originate from the aortic arch. The primary diffusion-weighted magnetic resonance imaging (DW-MRI) efficacy endpoint will use a novel adaptive statistical approach that includes pre-specified interim analyses with the possibility of early study completion in the instance of superiority. The primary safety endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) assessed at 30-days.
The trial will be led by Dr Susheel Kodali (New York Presbyterian Hospital, NY, USA), Dr Raj Makkar (Cedars Sinai, Los Angeles, CA, USA) and Dr Stephan Haussig (Herzzentrum, Dresden, Germany), as the designated Global Co-Principal Investigators, with Dr Roxana Mehran (Mount Sinai, NY, USA) as the Chair of the Study Executive Committee.
“The novel adaptive statistical design of this clinical study will answer several important unanswered questions about the role of three-vessel cerebral protection in reducing new lesions in all areas of the brain,” said Dr Mehran. “The results will give the physician community increased confidence in offering patients cerebral protection when they undergo their TAVR procedures.”
“We are proud to be the first center to enroll a patient into this innovative international study,” said Dr Kodali. “The requirement for DW-MRI assessment means that we will be able to accurately quantify the fundamental effect of the technology on reducing the size and frequency of new cerebral lesions, which are very common during the TAVR procedure.”
“We are delighted to announce that the first patient has been enrolled in the trial, and that we are executing a cadenced plan to activate the other investigational sites in the next few months. We would like to express our gratitude to the teams at the sites for the hard work that each has invested in the study startup phase. This significant progress reflects the close collaboration between our study executive committee, our clinical research organization, and core lab partners in planning this complex trial,” said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis.
About ProtEmbo® and Protembis
The ProtEmbo® Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during TAVR. It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment typically delivered through the femoral artery.
Protembis is a privately held emerging medical device company that has developed the ProtEmbo ® Cerebral Protection System. The company strives to provide 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 such procedures. The ProtEmbo ® System is currently undergoing clinical investigations.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240401785393/en/
Contact information
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
+49(0)241 9903 3622
management[at]protembis.com
www.protembis.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Enerin raises €15 million Series A to industrialise modular high-temperature heat pumps for global industry26.11.2025 11:00:00 EET | Press release
Enerin, a technology leader in high-temperature heat pumps, has raised €15 million (NOK 180 million) in a Series A led by Climentum Capital, The Footprint Firm, Johnson Controls and Move Energy, with participation from PSV Hafnium and Momentum. “This investment marks our shift from pioneering to full industrialisation, bringing proven high-temperature technology from Norway to industries worldwide,” said Arne Høeg, Founder and CEO of Enerin. “Industrial companies are ready to decarbonise high-temperature heat, but the mass market has lacked simple, profitable solutions that fit everyday operations.” Replacing fossil-fuelled industrial boilers — responsible for nearly 20% of global CO₂ emissions — remains one of the toughest challenges in the energy transition, largely because conventional heat pumps can’t cope with the sector’s highly variable process conditions and high temperatures. Enerin’s modular, flexible and standardised system removes such barriers by adapting automatically to
IQM to Invest Over €40 Million to Expand Finland Production Facility, Accelerate Innovation and Fuel Growth26.11.2025 10:49:00 EET | Press release
IQM Quantum Computers, a global leader in superconducting quantum computers, today announced over €40 million investment to expand its state-of-the-art production facility in Finland. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251126943986/en/ This strategic expansion will accelerate the development, fabrication and testing of advanced quantum processing units and the assembly of quantum computers, paving the way for scalable, error-corrected quantum systems that will power the next era of computing. The expansion aligns with the company’s recent Series B fundraise of over $300 million. The facility, which will spread over 8,000 square meters, will expand the company’s cleanroom area quantum data centre. It will also double its assembly line capacity, enabling to produce over 30 full-stack quantum computers per year, helping to meet the growing demand for its systems and support research innovation and development activi
Thredd Powers Successful Migration of BigPay’s Card Portfolio to Next-Gen Platform26.11.2025 10:00:00 EET | Press release
Thredd, the leading next-generation global payments processor, has successfully migrated BigPay’s virtual and physical card portfolio from its previous, legacy processor to Thredd’s next-generation platform, underscoring Thredd’s leadership in complex card portfolio migrations. The migration project, one of several in recent years, included over 2.5 million cards and highlights Thredd’s unique combination of deep migration experience, robust processes, and advanced technology—qualities increasingly critical as the industry faces a wave of modernisation and replatforming. This achievement comes at a pivotal moment for the industry. Industry analysts estimate that retail banks failing to modernise could see 10% to 15% of their payments revenue at risk annually as legacy platforms struggle to keep pace with demands for hyperpersonalization, digital experiences, faster time-to-market, and operational efficiencies. With more than 100 million cards per year expected to move to modern platfor
With Two in Five Employees Undergoing Fertility Treatment Leaving Their Jobs or Considering Quitting, Are Companies Doing Enough?26.11.2025 09:00:00 EET | Press release
An international survey, spanning Australia, France, Japan, Poland and the UK, has found that many employees experiencing fertility challenges lack support in the workplace, with almost two in five (39%) leaving or considering leaving their roles while undergoing treatment.1 ‘The Impact of Fertility Challenges at Work: International Insights’ survey by Ferring Pharmaceuticals, Fertility Matters at Work and This Can Happen shows that, despite growing awareness of reproductive health, two thirds (67%) who have experienced fertility challenges say that their workplaces do not offer support for employees undergoing fertility treatment, with France the least likely to provide it (88%).1 60% said they were not clearly entitled to time off for fertility appointments, with time recorded as paid leave, unpaid leave or annual leave (26%), and some also reported taking sick leave due to a lack of flexibility (17%).1 With assisted reproduction therapy, including IVF, already accounting for up to 1
Venture Global and Tokyo Gas Announce 20-Year LNG Sales and Purchase Agreement26.11.2025 02:00:00 EET | Press release
Today, Venture Global, Inc. (NYSE: VG) and Tokyo Gas Co., Ltd announced the execution of a new, long-term liquefied natural gas (LNG) Sales and Purchase Agreement (SPA). Under the SPA, Tokyo Gas will procure 1 million tonnes per annum (MTPA) of LNG from Venture Global for 20 years, starting in 2030. This deal marks 7.75MTPA of SPAs signed by Venture Global in the last six months. “With nearly 8 MTPA of new long-term commitments signed this year, Venture Global is pleased to build on our commercial momentum through this new partnership with Tokyo Gas,” said Venture Global CEO Mike Sabel. “Tokyo Gas is a pioneer in the LNG industry and leading provider of natural gas to Japan, and we look forward to working with them as we grow our position as a top LNG supplier to Japan. This agreement will contribute significantly to the US-Japan balance of trade over the duration of the SPA, providing Japan with affordable, reliable American LNG.” About Venture Global Venture Global is an American pro
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