A New Challenger Enters the Endovascular Arena

A new player in the endovascular space for pulmonary embolism (PE) will soon begin a pivotal clinical trial.

The trial will study the Vertex Pulmonary Embolectomy System with Endoportal Control technology from Menlo Park, CA-based Jupiter Endovascular.

The technology was developed within Neptune Medical beginning in 2020. Jupiter was allocated $21 million of Neptune’s $97 million Series D financing to spin off as a standalone company in July.

Sonder Capital is a major contributor to the round.

“Endovascular therapies have faced the same fundamental limitations since the first percutaneous coronary intervention was performed almost half a century ago,” said Jupiter CEO Carl St. Bernard, MBA, who assumed the position in July. St. Bernard most recently was president and CEO of Alta Biomaterials.

“The further physicians advance catheters through tortuous anatomy, the less control they have in delivering transcatheter therapies,” St. Bernard told MD+DI. “Operators often have to choose between catheter flexibility and pushability.”

Catheter systems that are too flexible may not be able to effectively deliver a therapy, whereas catheters that are too stiff can injure the anatomy.

PE is the first indication Jupiter is pursuing. St. Bernard noted that one in three patients receives incomplete treatment for PE, leaving clot in their pulmonary arteries.

“This leftover clot is associated with long-term physical limitations and decreased quality of life, often forming chronic lesions from which many patients never fully recover,” he said.

For today’s thrombectomy procedure, conventional catheters may not be able to access hard-to-reach vessels, and some physicians abort the thrombectomy procedure early because of safety concerns, including the risk of intraoperative cardiovascular collapse due to right heart strain during the procedure, according to St. Bernard.

The Endoportal Control platform technology is designed “to bring unprecedented precision and control to catheter interventions, by creating a stable channel within the vessel through which instruments and interventions can be precisely delivered, without recoil or loss of position, even in areas of tortuosity or lack of anatomical support,” St. Bernard said.

The level of precision and control provided by the technology is designed to be similar to what a surgeon experiences with direct visual access in open-surgical procedures but in a catheter-based procedure.

The device uses hydrostatic pressure to switch a catheter between relaxed and fixed states.

In treating PE, a physician navigates the endoportal device in its flexible, relaxed state over a guidewire to the targeted location in the pulmonary arteries. The physician then pressurizes the device with saline to fix it in a stable position for the embolectomy.

“Once completed, the physician relaxes the device into its flexible state by depressurizing the device, to navigate to another therapeutic location or for removal,” St. Bernard said. “The device can be relaxed and/or fixed as many times as is necessary during a procedure.”

To date, the technology has been used in more than 25 animal studies by interventionalists across a variety of specialties. “In these studies, the device demonstrated safe and easy navigation through the heart and vasculature, as well as effective delivery of test interventions,” St. Bernard said.

As with any new technology, there is a learning curve; the tactile feel of the device is different from traditional catheter interventions. “However, physicians tell us they quickly become comfortable with the device, in what may be as little as a single case,” St. Bernard said.

Jupiter estimates its PE system has the potential to improve outcomes for up to half of the 600,000 patients treated for PE annually in the U.S. 

The company expects to commence the pivotal trial for acute PE later this year, which will then be submitted to FDA for 510(k) clearance.

“Our technology and its associated procedures have the potential to not only improve upon existing procedures but to create new cardiovascular therapies previously unobtainable via percutaneous access,” St. Bernard said. “We believe this represents the biggest leap forward for patients, physicians, and endovascular medicine in general in almost 50 years.”