Jupiter Endovascular, which was formed by Neptune Medical a little more than a year ago, shared positive results from the first-in-human trial of its Vertex TFX catheter platform.
As part of its Vertex system, the TFX platform is designed to allow practitioners to treat areas in the human body that are not safely or easily reached using more conventional endovascular systems.
Results from the SPIRARE I trial of Jupiter’s Vertex Pulmonary Embolectomy System that treated patients with acute, intermediate-risk pulmonary embolism showed there were no major adverse events, including major bleeding, within 48 hours of the procedure.
Additionally, 80% of the procedures were completed without re-crossing the heart, and 70% of procedures were completed without use of a stiff guidewire, the company said in an Oct. 26 press release.
Of the test subjects, 32% saw improvement in mean pulmonary artery pressure.
The study, which was based on 10 patients and conducted at two sites in Austria and Poland, was recently presented at the Transcatheter Cardiovascular Therapeutics conference in San Francisco.
“Pulmonary embolism remains an area of major unmet need—both in the acute phase and over the long term—where its sequelae may contribute to chronic heart failure,” Irene Lang, M.D., the principal investigator and a professor at the Medical University of Vienna, said in the release. “In this study, the vast majority of procedures were completed without the need to re-cross the heart or use a stiff guidewire, and the data demonstrated an excellent safety profile with marked improvements in right heart function and overall clinical recovery.”
“Together, these findings underscore the promise of this technology for pulmonary embolism and cardiovascular disease,” said Lang.
Earlier this month, Jupiter raised $40 million in series B fundraising slated to further develop and launch its TFX platform. That fundraising haul followed the FDA giving the Vertex Catheter system that incorporates the TFX platform 510(k) clearance in September that allows devicemakers to legally market medium-risk devices in the U.S.