Transverse Medical’s Point-Guard Trial Underway in Australia

Transverse Medical Inc. has completed the first series of patients in its Point-Guard feasibility clinical study in Melbourne, Australia. Patients undergoing TAVR procedures (Transcatheter Aortic Valve Replacement) were treated using the company’s next-generation Point-Guard Cerebral Embolic Protection (CEP) device.

The study was executed at Victorian Heart Hospital in a timely and efficient matter, representing a significant advancement for the company and in cerebral embolic protection. “We are proud of the progress we’ve made with the Point-Guard CEP technology,” said Dr. Michael Reardon, chief medical officer at Transverse Medical and a 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 aims 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 device’s simple design, operator ease of use, and complete coverage of all major arch vessels provides a positive outlook for enhanced patient safety and improved clinical outcomes, according to the company.

Dr. Robert Gooley, a physician investigator at Victorian Heart Hospital, offered his perspective on procedures and device itself. “Point-Guard was easy to use, simple to deploy and retrieve, and was free of adverse events in this first phase of the study,” he noted. “Positioning 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.”

With the first series of patients treated under the feasibility study, Transverse Medical has taken its first step to improving patient safety and outcomes during TAVR procedures. 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.

“We would not be where we are today without the support of our investors, whose confidence in our mission has been instrumental,” Transverse Medical President/CEO Eric Goslau stated. “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.”

Transverse Medical is an early-stage medical device company developing the Point-Guard Cerebral Embolic Protection device for use during TAVR surgeries to protect patients from embolic debris (particles) that is dislodged and released (debris shower) into the cerebral blood flow. This debris shower could lead to periprocedural stroke as a result of the TAVR procedure.

Point-Guard is currently in development and has not been approved for human use by the U.S. Food and Drug Administration.