Transverse Medical has announced the completion of the first series of patients under its feasibility clinical study at the Victorian Heart Hospital in Melbourne, Australia. Patients undergoing transcatheter aortic valve implantation (TAVI) procedures were treated using the company’s next-generation Point-Guard cerebral embolic protection (CEP) device, marking what Transverse describes as a “major milestone” in the clinical evaluation of this innovative technology.
“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 Robert Gooley (Victorian Heart Hospital, Melbourne, Australia), the study’s physician investigator. “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’s Point-Guard device is designed to provide maximum protection against periprocedural stroke and brain ischaemia during transcatheter procedures—such as TAVI—by preventing embolic particles from reaching the brain. The “innovative and simple” design of the device, in addition to ease of use for the operator, and the fact it represents a solution for “complete coverage” of all the major arch vessels, provides a positive outlook regarding enhanced patient safety and improved clinical outcomes. That is according to a Transverse press release.
“We are incredibly proud of the progress we’ve made with the Point-Guard CEP technology,” said Michael Reardon (Houston Methodist Hospital, Houston, USA), chief medical officer at Transverse. “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 TAVI, which will be life-changing for so many.”
“We would not be where we are today without the support of our investors, whose confidence in our mission has been instrumental,” added Eric Goslau, president and chief executive officer (CEO) of Transverse. “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.”
