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
Exeon Analytics expands management team for next growth phase2.9.2026 11:00:00 EEST | Press release
Exeon Analytics is expanding its management team with two new roles. Wayne Jennings takes on the newly created position of Chief Solutions Officer, and Johan Roman becomes Chief Revenue Officer. The appointments fall in the company’s anniversary year, ten years after its founding as an ETH Zurich spin-off, and create the structure for the next growth phase. Exeon Analytics delivers holistic security analytics for organizations facing growing blind spots, encrypted traffic and regulatory pressure. Wayne Jennings joined Exeon Analytics in July 2024 and initially led Support and Engineering. As Chief Solutions Officer, he is responsible for the technical customer lifecycle, from pre-sales and proof of concept through implementation to long-term technical account management, and for the technical enablement of partners. Before joining Exeon Analytics, he was a Senior Manager in Cybersecurity & Privacy at PwC Switzerland, focusing on threat intelligence and incident response. Johan Roman br
euroAtlantic Airways Expands Long-Haul Fleet With a New Airbus A330-300 Aircraft2.9.2026 10:00:00 EEST | Press release
euroAtlantic Airways (“EAA”), a Njord Partners portfolio company and a leading Portuguese aircraft wet-leasing and charter business, is pleased to announce the induction of a new Airbus A330-300 aircraft into its fleet, further strengthening its long-haul widebody capabilities and reinforcing the Company's growth trajectory in the ACMI and charter markets. The Airbus A330-300 is leased from Jackson Square Aviation (JSA). Only 15 years old, the aircraft is configured in a three-class layout of Business, Premium Economy and Economy, accommodating a total of 290 passengers, and features full lie-flat seating in Business Class along with personal in-seat entertainment monitors fitted across the entire cabin. The aircraft, which will be registered as CS-TGI after completing its normal process of approval with authorities, has already completed its delivery journey, departing Kuala Lumpur (KUL) and arriving into Beja, Portugal (BYJ) on 17 August 2026. This aircraft type is known for its effi
Interoperability and Trust Key to AI Commerce: Alipay+ and S&P Global Report2.9.2026 09:33:00 EEST | Press release
A new report by Alipay+, the unified wallet gateway of Ant International, in partnership with S&P Global, reveals a growing "commerce digitalisation gap", with people increasingly expecting seamless mobile payments and intelligent digital assistance, yet friction – from inconsistent payment acceptance to trust in AI – still define their experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901394299/en/ The study, which surveyed 6,000 consumers across nine markets in Asia, Europe and the US on their cross-border spending habits, points to a major shift underway in global commerce — one where e-wallets, AI and interoperable digital ecosystems are becoming foundational to how consumers discover, transact and engage across borders. Key findings: Travel exposes gaps in global commerce infrastructure: More than half of consumers cite uncertainty around merchant acceptance (53%) or lack of access to preferred payment metho
Kontoor Brands Unveils Helly Hansen Growth Strategy and 2030 Financial Targets2.9.2026 09:30:00 EEST | Press release
Kontoor Brands, Inc. (NYSE: KTB) today announced Helly Hansen’s long-term growth strategy and 2030 financial targets, which Kontoor Brands will present at the Helly Hansen® Investor Day later today. The plan is designed to scale Helly Hansen globally while significantly expanding its profitability through 2030. "With 150 years of technical heritage and an authentic right to win globally, Helly Hansen is a brand with tremendous long-term growth potential," said Scott Baxter, Chief Executive Officer and Chairman of the Board of Kontoor Brands. "Strong alignment between our teams has allowed us to integrate quickly and move straight to executing against the opportunity ahead. Our sustained investment in Helly Hansen will be a catalyst for its next phase of growth, and we are confident in our ability to deliver significant value for our consumers, employees and shareholders for years to come." A Focused Growth Strategy: To deliver against these targets, Helly Hansen’s growth is anchored in
Axelspace Announces Partnership with Airbus Defence and Space to Deliver Satellite Imagery to a Broader Market2.9.2026 09:30:00 EEST | Press release
Axelspace Corporation (“Axelspace”), a leading microsatellite company committed to making “Space within Your Reach,” announced today a new agreement with Airbus Defence and Space, a global leader in Earth observation including optical and radar satellite imagery, to provide mid-resolution optical images captured by Axelspace’s Earth observation microsatellites “GRUS.” Under this strategic partnership, we will develop and deliver innovative solutions that meet long-term customer needs for utilizing satellite imagery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901360086/en/ GRUS is Axelspace's series of approximately 100 kg-class optical Earth observation microsatellites. GRUS-1 is currently operated as a four-satellite constellation, delivering high-frequency, wide-area imagery. This imagery, together with value-added solutions derived through processing and analysis, supports a broad range of industries, including agr
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