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Medical device company marks trial milestone in the evaluation of its embolic protection device, creates expert advisory board as it navigates growth opportunity
TAMPA, Fla., Oct. 8, 2024 /PRNewswire/ — EMBLOK™ (emblok.com), a privately held medical device company developing the most comprehensive next-generation embolic protection device to reduce strokes, acute kidney injury (AKI) and other peripheral complications during transcatheter aortic valve replacement (TAVR), announced today that it has enrolled the first 50 patients in a clinical trial to evaluate the performance and treatment effect of its Emblok™ Embolic Protection System (EPS).
Explosive growth in TAVR volumes has been reported globally, with some growth rates >50-fold according to a report from the American Heart Association.1 The TAVR market is estimated to increase at a CAGR of 14.1% over the next decade in North America alone.2
TAVR, a transcatheter procedure, offers a less invasive option for aortic valve replacement in the heart. During the replacement of the aortic valve, small pieces of calcium or tissue can sometimes break off from the old valve. This debris, referred to as emboli, can travel through blood vessels to the brain, placing a patient at risk for stroke. An embolic protection device captures emboli and mitigates the risk of emboli breaking free, protecting other vital organs during TAVR procedures. EMBLOK’s EPS device aims to offer whole-body protection from debris captured during TAVR, reduce procedural complexity and improve patient safety.
“The enrollment of the 50th patient in our study for our novel whole-body embolic protection system is a major milestone for the advancement of safety in TAVR procedures,” said Brad Brown, CEO of EMBLOK. “Our mission is to provide a breakthrough solution that enhances patient safety during this increasingly prevalent procedure. The early results have been very encouraging, and we’re optimistic about the potential of this technology to set a new standard in embolic protection.”
The U.S. multicenter, single-blind, randomized controlled trial, “Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR,” will enroll up to 532 subjects between 18 and 90 years of age with aortic valve stenosis who are undergoing TAVR. The company is initiating additional clinical sites and plans to finish enrollment by Q3 2025. Hemal Gada, MD, president of the UPMC Heart and Vascular Institute in Central PA, medical director of the Structural Heart Program, and national principal investigator, and William Merhi, DO, FACC, EMBLOK founder, board-certified interventional cardiologist at Corewell Health and Fellow of the American College of Cardiology, are leading the clinical trial.
“Embolic protection is crucial during TAVR procedures to safeguard patients from the risk of stroke and other serious complications caused by debris dislodged during the procedure,” said Dr. Gada. “By ensuring comprehensive protection, we can significantly improve outcomes and enhance both the short and long-term quality of life for those undergoing this life-saving treatment.”
In addition to marking the 50th patient enrolled in its study, EMBLOK has appointed new Scientific and Strategic Advisors to help guide and support its clinical and operational work amid growing market opportunity. The advisors include: Dr. Gada and Dr. Merhi; Renu Virmani, MD, founder and board member of the CVPath Institute; Peter Fail, MD, Cardiovascular Institute of the South, where he joined in 1996; Ravi K Ramana, DO, interventional cardiologist at Advocate Christ Medical Center; Bassem M. Chehab, MD, FACC, interventional cardiologist, Kansas Heart Hospital; and Abhijeet Dhoble, MD, interventional cardiologist, Memorial Hermann.
Dr. Renu Virmani, an internationally renowned cardiovascular pathologist who is recognized as a leading researcher in cardiovascular disease treatments, said: “As the field of transcatheter aortic valve replacement continues to evolve, the importance of whole-body embolic protection has never been more critical. While current systems target cerebral protection, capturing and removing debris from the entire circulatory system offers a more comprehensive safeguard. Whole-body embolic protection represents the next frontier in ensuring patient safety by minimizing the risk of complications that can arise from debris dislodgement during TAVR procedures.”
“We’re thrilled to announce the formation of our advisory board, bringing together renowned experts who will help guide us as we continue advancing this important work and bring it to market,” continued Brown. “We see significant opportunities to, most importantly, support physicians performing TAVR procedures in their effort to optimize patient care, as well as play an integral role in the burgeoning TAVR market. These esteemed healthcare professionals will be instrumental to achieving our goals.”
For more information about EMBLOK and its whole-body EPS solution, visit emblok.com.
About Emblok
Emblok™ is a privately held, clinical stage medical device company designing and developing an innovative easy-to-use whole-body embolic protection system for heart and vascular interventions, protecting every major artery. Deployed during transcatheter aortic valve replacement (TAVR), an increasingly adopted minimally invasive treatment for aortic stenosis, Emblok™ Embolic Protection System (EPS) aims to safeguard cerebral, cognitive, kidney, and visceral artery function by capturing and removing embolic debris from all major arteries, significantly lowering risks of stroke, cognitive impairment, acute kidney injury (AKI), and vascular complications. For more information, please visit emblok.com.
Contact
Kate Ottavio Kent
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585.746.9801
1 https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.122.011827#T1
2 https://cardiovascularbusiness.com/topics/clinical/structural-heart-disease/tavr/transcatheter-heart-valve-replacement-19b
SOURCE EMBLOK™
