Point-Guard Protected™ Safeguard the Brain, Treat the Heart.
Transverse Medical Inc. is excited to announce the completion of the first series of patients under its Feasibility Clinical Study at the prestigious Victorian Heart Hospital in Melbourne, Australia. The patients undergoing TAVR procedures (Transcatheter Aortic Valve Replacement) were treated using the company's next generation POINT-GUARD™ Cerebral Embolic Protection (CEP) device, marking a major milestone in the clinical evaluation of this innovative technology.
The achievement was made possible by the hard work and dedication of the entire Transverse Medical team, as well as the collaborative efforts of the study's Physician Investigator, Dr. Robert Gooley, and the exceptional staff at the Victorian Heart Hospital. The study was executed in a timely and efficient matter representing a significant advancement for the company and in the field of cerebral embolic protection and underscores the commitment of everyone involved in the Point-Guard development and execution of the feasibility study.
"We are incredibly proud of the progress we’ve made with the Point-Guard CEP technology," said Dr. Michael Reardon, Chief Medical Officer of Transverse Medical Inc., and a globally renowned Cardiothoracic surgeon at Houston Methodist Hospital. "Complete embolic coverage of the aortic arch and the great vessels supplying blood to the brain is clearly the next step for the CEP market. The Point-Guard solution and technology brings us one step closer to providing Full Brain Protection for patients undergoing high-risk procedures like TAVR, which will be life-changing for so many."
Transverse Medical’s Point-Guard device is designed to provide maximum protection against periprocedural stroke and brain ischemia during transcatheter procedures, such as TAVR by preventing embolic particles from reaching the brain. The innovative and simple design of the device, operator ease of use, and solution for complete coverage of all the major arch vessels provides a positive outlook for enhanced patient safety and improved clinical outcomes.
Dr. Robert Gooley, Physician Investigator at Victorian Heart Hospital, offered his perspective on the completion of this first series of procedures. "Point-Guard was easy to use, simple to deploy and retrieve, and was free of adverse events in this first phase of the study,” said Dr. Gooley. "Positioning the Point-Guard in the arch anatomy was predictable and the asymmetric design of the filter provided a unique approach for complete coverage of all the major arch vessels."
Transverse Medical would also like to express its profound gratitude to its investors for their unwavering support. Without their continued belief in the potential of Point-Guard, this milestone would not have been possible. Their support has been crucial in driving the company’s progress and bringing the technology to this pivotal point.
"We would not be where we are today without the support of our investors, whose confidence in our mission has been instrumental," said Eric Goslau, President & CEO of Transverse Medical. "I want to extend my heartfelt thanks to the entire Transverse Medical team, Dr. Gooley and his team, the staff at Victorian Heart Hospital, our Medical Advisory Board, and our Board of Directors. This critical step in our Feasibility Study is a testament to their hard work, collaboration, and belief in the potential of Point-Guard."
With the first series of patients treated under the Feasibility Study, Transverse Medical is on a positive path forward to achieving its goal of improving patient safety and outcomes during TAVR procedures. The company remains committed to advancing this technology and bringing full brain protection to patients worldwide.
About POINT-GUARD™ and Transverse Medical, Inc.
Transverse Medical is an early-stage medical device company focused on the development of the POINT-GUARD™ Cerebral Embolic Protection medical device for use during Transcatheter Aortic Valve Replacements (TAVR) to protect patients from embolic debris (particles) that are dislodged and released (debris shower) into the cerebral blood flow that could lead to periprocedural stroke as a result of the TAVR procedure.
The next generation Point-Guard is a breakthrough advancement for complete Cerebral Embolic Protection of the brain and designed with operator ease of use and ability to accommodate variable arch anatomies with non-interference and full aortic arch stabilization.
Notice: The POINT-GUARD™ is currently in development and has not been approved for human use by the US FDA. Point-Guard is being used in a clinical trial in Australia conducted under the Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme.
To Learn More about Transverse Medical: www.transversemedical.com
Follow Transverse Medical Company: https://www.linkedin.com/company/9241257
Follow CEO, Eric Goslau linkedin.com/in/eric-goslau-4721261a
View source version on businesswire.com: https://www.businesswire.com/news/home/20250421500463/en/
"Point-Guard was easy to use, simple to deploy and retrieve, and was free of adverse events in this first phase of the study”
Contacts
Eric Goslau, President & CEO, Info@TransverseMedical.com
