Jupiter Endovascular's Vertex TFX Catheter Platform Shows Promise in First-in-Human Trial

Jupiter Endovascular, a company formed by Neptune Medical just over a year ago, has announced positive results from the first-in-human trial of its innovative Vertex TFX catheter platform. The study, known as SPIRARE I, focused on treating patients with acute, intermediate-risk pulmonary embolism and demonstrated encouraging outcomes in both safety and efficacy.

Promising Clinical Results

The SPIRARE I trial, conducted at two sites in Austria and Poland, involved 10 patients and yielded several noteworthy findings:

• No major adverse events, including major bleeding, were reported within 48 hours of the procedure.
• 80% of procedures were completed without re-crossing the heart.
• 70% of procedures were performed without the use of a stiff guidewire.
• 32% of patients experienced improvement in mean pulmonary artery pressure.

Dr. Irene Lang, the principal investigator and a professor at the Medical University of Vienna, emphasized the significance of these results, stating, "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." She added that the data "demonstrated an excellent safety profile with marked improvements in right heart function and overall clinical recovery."

Technological Advancements

The Vertex TFX platform, a key component of Jupiter Endovascular's Vertex system, is designed to allow practitioners to access and treat areas of the human body that are typically challenging or unsafe to reach using conventional endovascular systems. This technological breakthrough has the potential to significantly impact the treatment of pulmonary embolism and other cardiovascular diseases.

The recent FDA 510(k) clearance of the Vertex Catheter system, which incorporates the TFX platform, marks a crucial milestone for Jupiter Endovascular. This regulatory approval allows the company to legally market the medium-risk device in the United States, paving the way for broader clinical application.

Financial Backing and Future Developments

Jupiter Endovascular's innovative approach has attracted significant financial support. Earlier this month, the company successfully raised $40 million in a Series B funding round. These funds are earmarked for further development and launch of the TFX platform, underscoring investor confidence in the technology's potential.

As Jupiter Endovascular continues to advance its Vertex TFX catheter platform, the positive results from the SPIRARE I trial and the recent FDA clearance position the company as a promising player in the treatment of pulmonary embolism and other cardiovascular conditions. The medical community eagerly anticipates further developments and potential applications of this groundbreaking technology.