Protembis Announces First Patient Enrolled in the PROTEMBO IDE Pivotal Trial
2.4.2024 08:00:00 EEST | Business Wire | Press release
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
Ryan Expands Global Presence and European Reach Through Acquisition of Svalner Atlas Advisors1.6.2026 12:00:00 EEST | Press release
Ryan, LLC (“Ryan”), a leading global tax services and software provider, today announced it has entered into a definitive agreement to acquire Svalner Atlas Advisors, a premier independent tax and transaction advisory firm headquartered in Stockholm, Sweden. The acquisition will expand Ryan’s presence across the Nordics and Benelux regions while enhancing the Firm’s ability to deliver integrated cross-border tax and advisory services throughout Europe. Founded through the combination of three leading advisory firms in Sweden, Finland, and the Netherlands, Svalner Atlas Advisors has established itself as a leading independent advisory group in the region. Today, the firm includes more than 450 professionals and 50 partners serving more than 4,000 clients across five countries, with offices in Stockholm, Amsterdam, Helsinki, Oslo, Copenhagen, Gothenburg, and Turku. “This transaction is an important milestone in Ryan’s continued European growth strategy,” said G. Brint Ryan, Chairman and
Electricity System Transformation Vital to Meet Future Needs, Arthur D. Little Blue Shift Report Finds1.6.2026 12:00:00 EEST | Press release
Arthur D. Little (ADL)’s Blue Shift Institute today published The Future of Electricity - From Building Capacity to Shaping Flexibility. The in-depth new report explores the growing pressures on electricity systems worldwide, and how they must transform to meet radically changing needs. With demand predicted to rise by 40-55% by 2035, it identifies practical strategies for maintaining reliability, affordability, and resilience. Electricity systems face profound challenges due to the accelerating electrification of end uses, increasing renewables deployments, and the digitalization of economies. Rising variability and system stress is already leading to instability, grid congestion, and disruption. Demonstrating this, an April 2025 blackout across the Iberian Peninsula led to at least eight deaths and an estimated US $1.8 billion in economic losses. Based on in-depth research and expert interviews, the report outlines the need to reshape infrastructure and operations to move from supply
Procore Redefines the Common Data Environment with Connected Data and Agentic AI1.6.2026 11:00:00 EEST | Press release
Procore Technologies, Inc. (NYSE: PCOR), the leading global provider of construction management software, today announced the launch of its connected Common Data Environment (CDE)—a purpose-built CDE from the ground up on a single platform to unify and verify project data from approved design to handover, capturing evidence in the flow of work to help keep the digital record aligned with site reality. This trusted data foundation allows agentic AI to act across the full construction lifecycle. In an industry where fragmented information continues to slow decision-making and contribute to costly delays, connected data is increasingly defining top-performing organizations. New research from Dodge Construction Network* found firms with optimized data practices achieve up to 23% higher productivity, manage 27.8% greater construction volume using the same resources, and reduce project delays by more than six days. Those firms also report up to 40% stronger overall performance, highlighting
AI Investment Boom Across the UK is Fuelled More by Fear of Missing out Than Actual Results, According to Expereo1.6.2026 11:00:00 EEST | Press release
Enterprise AI spending is climbing rapidly, with boards racing to deploy the technology faster than they can measure whether it works. According to the latest IDC InfoBrief, commissioned by Expereo*, around 70% of organizations are investing in AI, motivated by its potential or by the fear of falling behind the competition, but they lag in disciplined ROI evaluation, and one in five (20%) admit they are investing aggressively in AI with little evaluation, driven by the fear of being left behind. The IDC InfoBrief, based on a survey of 800 technology leaders across Europe, the US, and APAC, found that AI has become one of the most prioritized technology investments globally. When asked which technologies their organization will prioritize in terms of effort and/or financial investment over the next 12 months, 51% of organizations said AI or ML. However, returns are failing to keep pace with the hype. Just 19% of global organizations surveyed say their AI implementations have exceeded ex
Corient Completes Acquisitions of Stonehage Fleming and Stanhope Capital Group; Global Assets Surpass US$500 Billion1.6.2026 09:15:00 EEST | Press release
Corient today announced the successful completion of its previously announced acquisitions of Stonehage Fleming and Stanhope Capital Group, marking a significant milestone in its continued global expansion. “This is an exciting moment for Corient and the clients we serve around the world,” said Kurt MacAlpine, Founding Partner and Chief Executive Officer of Corient. “We are thrilled to welcome our new Partners at Stonehage Fleming and Stanhope Capital Group to Corient as we continue building a truly global firm defined by partnership, collaboration and an unwavering commitment to client excellence.” With today’s announcement, Corient becomes the world’s largest non-bank wealth manager and multi-family office focused on ultra-high- and high-net-worth clients. The firm, established in 2020, operates under a client-first approach with complete fee transparency. Corient operates under a distinctive private partnership model, similar to those used by leading professional services firms, tha
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