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
Netmore Named Smart Company of the Year at the Premios iAgua 20261.10.2026 20:00:00 EEST | Press release
Netmore Group, the leading network operator and platform provider for Massive IoT, today announced it has been named Empresa Smart del Año — Smart Company of the Year — at the Premios iAgua 2026, the awards of iAgua, the Spanish-speaking water sector's leading media platform. The award was presented at the closing gala of the Spain Smart Water Summit, held at the Meliá Avenida América in Madrid. The award recognises a company that has taken an unusual route into water. Netmore is not a technology firm that added connectivity to its portfolio: it is a network operator that decided to specialise in the water cycle. In eighteen months, it has completed four acquisitions and become the world's largest LoRaWAN® network operator, with more than eighteen million IoT devices under contract across more than fifty countries. Its commitment to Spain took concrete form with the acquisition of Arson Metering, the Bilbao-based remote reading specialist, which brings a portfolio of more than 500,000
Elliptic Sets the Engineering Bar for On-Chain Risk With “Built for Compliance” Paper as New Rules Take Hold and Banks Launch a Joint Stablecoin1.10.2026 16:40:00 EEST | Press release
Elliptic, the global leader in on-chain risk management, today published Built for compliance, a paper setting out the nine engineering decisions that determine whether an on-chain risk system can support fast, accurate and defensible compliance decisions at agentic scale. Machines are already moving money on their own, at machine speed. Compliance teams now have to make hundreds of thousands of decisions a day, at that same speed. However, many on-chain risk systems were never engineered to support that pace. A compliance system that computes exposure on a schedule delivers stale results. One that defines blockchain coverage loosely enough lets a screening miss exposure entirely. A system that skips testing disaster recovery, a spike or an outage, takes down the customer’s compliance system too. That gap between machine speed and system design is exactly what regulators are now closing. As US regulators put together market-structure regulation, the GENIUS Act's stablecoin rules take h
Andersen Global Enhances Pakistan Legal Presence with New Member Firm1.10.2026 16:30:00 EEST | Press release
Andersen Global strengthens its legal presence in Pakistan as Samdani & Qureshi, a collaborating firm since 2021, rebrands to Andersen Legal in Pakistan and is the latest member firm to join the organization. Headquartered in Islamabad, Andersen Legal in Pakistan advises domestic and international clients, including businesses, investors, financial institutions, public sector entities, development organizations, and individuals, on legal, commercial, and regulatory matters. The firm also handles arbitration and dispute resolution, advising on complex transactions, investments, finance, projects, and contentious matters in Pakistan and across borders. “Our approach is grounded in senior attention, clear communication, and disciplined analysis, with a focus on delivering advice that clients can put into action,” said Nudrat Ejaz Piracha, partner at Andersen Legal in Pakistan. “Joining Andersen Global enables us to build on this approach by drawing on additional capabilities and perspecti
Impartner Releases AI Ecosystem Playbook to Help Organizations Move from AI Experimentation to Execution1.10.2026 16:00:00 EEST | Press release
Impartner, the world’s leading partner revenue orchestration platform, today announced the release of its AI Ecosystem Playbook, a new resource designed to help leaders and teams assess their current AI capabilities, identify areas where AI can support business goals, and develop a practical path to implementation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261001661549/en/ Impartner’s AI Ecosystem Playbook helps organizations assess AI readiness and identify opportunities to apply AI across PRM 3.0, partner revenue orchestration, and the partner lifecycle. As AI moves from experimentation into everyday operations, companies need more than a collection of potential applications. They need a framework for understanding where they are ready to apply AI, where foundational gaps could limit its impact, and which opportunities should be prioritized. Impartner’s AI Ecosystem Playbook provides guidance through a maturity model,
Whiteford Adds Six Partners in New York City, Expanding its Litigation, International and Corporate Practices1.10.2026 16:00:00 EEST | Press release
Whiteford, Taylor & Preston, a full-service law firm with offices across the East Coast, today announced that six partners from Chambers-rated Lazare Potter Glazer & Moyle LLP have joined Whiteford’s New York office: David E. Potter, James F. Moyle, Johannes K. Gäbel, Jaipat Singh Jain, Anna Pia D. Felix and Jacob Englander. This team expands Whiteford's New York office to more than two dozen attorneys and deepens the firm's commercial and securities litigation, employment, cross-border and corporate capabilities in the New York market. The six partners bring decades of combined experience representing mid-market companies, investment advisers, hedge funds, foreign corporations, entrepreneurs and executives in litigation, regulatory investigations, and complex business transactions. "We are expanding with our clients, our markets and our reputation," said Martin Fletcher, Whiteford's Managing Partner. "This team validates our approach. Whiteford’s platform is designed to help grow and
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