Transverse Medical, Inc.
Eliminating the Risk of Stroke

The recent improvements in valve technology and delivery systems have helped address many of the known procedural co-morbidities. However, while the rate of clinical stroke (major stroke) has decreased compared to initial TAVR experiences, it continues to remain a major concern and is the most feared complication by patients undergoing structural heart procedures. Also, the use of modern neuro-imaging with MRI suggests that new ischemic lesions (any damage to the brain) post-TAVR occur more frequently.

Despite the advancements in TAVR devices and components, operator learning curve, and improvement in clinical outcomes after TAVR, there is a growing need to protect a patient’s brain from debris released during the TAVR procedure. In fact, TAVR stroke rates remain unacceptably high and even greater in magnitude compared to PCI despite improved equipment, techniques, and application/access to lower-risk patients. Needless to say, a stroke rate of zero is without question the end goal, but even a stroke rate of one percent or greater is unacceptable.To this end, the market currently needs the next generation of cerebral embolic protection devices (CEPD).

Enter Transverse Medical.

Transverse Medical is driven by the mission to minimize or eliminate the risk of stroke. The company’s first-in-human clinical study verified that the major challenge for a highly successful CEPD was that the design must be adaptable to a wide variety of aortic arch anatomies encountered during TAVR procedures while simultaneously providing full coverage of the great arch vessels. That’s where the development of the next generation POINT-GUARD™ implements a proprietary asymmetric 3D design, coupled with a novel approach and scientific use of flat-nitinol. This fully addresses the required multiple vector forces necessary for aortic arch stabilization and effective perimeter seal. Furthermore, the result achieved by the development of the Aortic Cantilever Spring™ provides for auto-responsive positioning and a self-righting mechanism that ensures the maximum protection of the brain that is reproducible, repeatable, and easy to use.

Eric Goslau, the CEO of Transverse, mentions, “The POINT-GUARD™ is a solution to the proverbial missing piece of the puzzle. Just as Scientists and Physicians base much of their decisions and practices on data information, developers of important medical devices that can save patients’ lives apply the same reasoning, when trying to solve an unmet clinical need.” The value of information throughout each phase of development cannot be overlooked or underappreciated. “You can do all the bench testing and pre-clinical work that will de-risk and increase overall confidence, but you will never know what you truly have achieved (or may achieve) until you put your technology in human patients,” says Goslau.

In early 2019, the company’s first-generation POINT-GUARD™ was tested in a series of first-in-human (FIH) patients by Dr. Axel Linke, at Dresden Medical Center in Dresden, Germany. The FIH experience verified that the key to enhanced performance of the Point-Guard in the wide variety of TAVR aortic arch anatomies would require a new way of thinking and innovation not yet observed in prior generations or other known competitive CEP devices. One of these key design characteristics is the application of an asymmetrical design. Dr Linke subsequently presented the findings in the Innovation Theater during the globally recognized TCT conference in 2019. Transverse Medical’s clinical steering committee—Dr. Mike Reardon, Houston Methodist Texas, Dr. Samir Kapadia, Cleveland Clinic Ohio, and Dr. Axel Linke, Dresden Medical Center Germany—then further defined (and simplified) the required success criteria for a next-generation cerebral embolic protection device: Maximum Protection/Coverage of all Great Arch Vessels, Anatomical Conformity that accommodates nearly all patient anatomies, reliable Stabilization throughout the procedure, and Operator Ease of Use.

The next generation POINT-GUARD™ is different from the Sentinel™ and other known CEP devices in development as it is scientifically designed and engineered to address the unmet need for full coverage in a variety of ways. “In fact,” says Goslau, “The POINT-GUARD™ is a symphony of key vector forces that come together in harmony to deliver a solution for maximum protection.” Despite the impact and delays of the Covid-19 Pandemic in 2020, Transverse has moved into design freeze for the next generation POINT-GUARD™ and continued their milestone schedule. The next key steps for Transverse are to complete a Series B round of financing and gain FDA IDE approval for an Early Feasibility Study that will be used to inform and structure a successful Pivotal study leading to 510k market clearance. The company will also continue to address the need to completely protect the brain during all procedures.