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
iQmetrix to Deliver 2026 Telecom Industry Address and Product Announcements, Unveiling the Next Wave of Intelligent Commerce14.9.2026 20:40:00 EEST | Press release
iQmetrix, the global provider of Intelligent Commerce Operating Systems for telecom, today opened registration for the 2026 Telecom Industry Address and Product Announcements, taking place Wednesday, October 28, 2026. For the first time in the event's history, iQmetrix will run two dedicated virtual sessions: one built specifically for European audiences, alongside its long-running North American event. Both are free to attend. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914992633/en/ Now in its seventh year, the Industry Address has become the telecom channel's annual checkpoint: an unfiltered read on where the market is heading, delivered by a company that sits at the intersection of telcos, retailers, and the partners who serve them. The 2026 edition draws on a year of research and direct conversations across international markets. "We spend the year listening — to telcos, to retailers, to the partners building alon
The Estée Lauder Companies Announces Partnership with Profound to Expand AI Visibility Across Its Global Brand Portfolio14.9.2026 19:32:00 EEST | Press release
The Estée Lauder Companies Inc. (NYSE: EL) today announced a global strategic partnership with Profound, the category-defining AI marketing platform, advancing its ambition to be prestige beauty’s leader in AI-native discovery. The partnership will provide the company with visibility into how its full portfolio of brands is represented across leading generative AI platforms, as well as opportunities to optimize that representation. This partnership establishes the company as the first in prestige beauty to deploy Profound’s capabilities globally across the company’s full portfolio and operationalize Generative Engine Optimization (GEO) and AI marketing at scale. As consumers increasingly turn to ChatGPT, Gemini, and other AI assistants to discover products, compare recommendations, and seek personalized beauty advice before a purchase, The Estée Lauder Companies is partnering with Profound to define the next era of beauty discovery. This partnership will equip the company with a unifie
AMAALA Yacht Club Opens, Putting the Red Sea on the Global Yachting Map14.9.2026 19:00:00 EEST | Press release
Red Sea Global (RSG), the regenerative tourism developer, has announced that AMAALA Yacht Club has officially begun operations, marking a major milestone in establishing the Saudi Red Sea as a new global destination for luxury yachting, sailing and marine tourism. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914160771/en/ AMAALA Yacht Club, the new luxury yachting destination on Saudi Arabia’s Red Sea coast. Nestled within AMAALA Marina Village, the AMAALA Yacht Club is now welcoming founding members and visiting yachts to moor and explore the destination. Located approximately 2,000 nautical miles from Monaco, the club provides a new winter destination for the world’s luxury sailing community, which traditionally migrates from the Mediterranean to the Caribbean or Indian Ocean from October. Positioned closer to the Mediterranean than the Caribbean, AMAALA offers an attractive winter cruising hub and a strategic gateway
Behind the Stage Lights: How Students Learned to Trust Their Voices with Doha Debates14.9.2026 16:40:00 EEST | Press release
During high school years in Model United Nations, Dahlia Al-Ansari learned to argue on behalf of a country she was assigned to represent. But when Doha Debates invited her to join a town hall debate in Toronto this July, she faced an unfamiliar challenge: sharing her own beliefs about a timely issue. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914150232/en/ Students from Qatar, Canada and Mexico during their visit to the University of Toronto as part of the Doha Debates Town Hall experience in Canada. (Photo: AETOSWire) An 18-year-old biological sciences student at Carnegie Mellon University in Qatar, Al-Ansari hadn’t traveled to defend a predetermined position. Instead, she discovered that she was there to think critically, express her own viewpoint and remain open to diverse perspectives. This shift required her to navigate uncharted waters, but “I’m happy that it did,” she says. “It’s showing me the importance of sp
Matt Shafer Joins Golub Capital as Head of Golub Equity Continuation Partners14.9.2026 16:30:00 EEST | Press release
Golub Capital (“the Firm”) today announced the appointment of Matt Shafer as Managing Director and Head of the Firm’s GP-led private equity secondaries strategy, Golub Equity Continuation Partners (“GECP”). In this role, he will be responsible for leading the continued growth and development of the strategy and helping expand the Firm’s equity investment capabilities. Matt will work closely with Greg Cashman, Vice Chair and Co-Head of Golub Capital’s Sponsor Finance practice, to expand Golub Capital’s activity in this growing market. Shafer brings nearly three decades of global experience as an investor, financier and advisor working with private equity firms. He was most recently Head of Capital Solutions and U.S. Private Equity at Northleaf Capital Partners. In this role, Shafer helped lead the firm’s private equity investment activities, including secondaries, co‑investments and structured capital. Prior to Northleaf, he was Partner and Head of Americas Private Equity at Vision Capi
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