Inari Medical’s PEERLESS Trial Evaluating FlowTriever Versus CDT for Intermediate-High Risk PE Enrolls First Patient

February 15, 2022—Inari Medical, Inc. announced that the first patient has been enrolled in the PEERLESS randomized controlled trial that aims to compare the outcomes of patients with intermediate-high risk pulmonary embolism (PE) treated with the FlowTriever system versus catheter-directed thrombolysis (CDT).

The first patient was enrolled by Amir Kaki, MD, at Ascension St. John Hospital in Michigan.

“We are excited and honored to enroll the first patient in this landmark clinical trial,” said Dr. Kaki. “From our own experience, the FlowTriever system has the potential to change the way we treat PE patients, safely removing significant clot burden while avoiding thrombolytics and procedure-related [intensive care unit] stay. Ascension St. John’s research team continues to be on the cutting-edge of medical device research and we look forward to contributing and developing the evidence base for the treatment of pulmonary embolism.”

Commenting in Inari’s announcement, Carin Gonsalves, MD, the Global Co-Principal Investigator for PEERLESS said, “The start of PEERLESS represents an exciting milestone in the advancement of PE treatment, where randomized clinical data evaluating relevant patient outcomes has been limited.

“PEERLESS marks an opportunity to directly compare FlowTriever outcomes to CDT outcomes, addressing current gaps in our understanding of PE and providing critical information to clinicians on the optimal treatment for these patients.” Dr. Gonsalves is Professor of Radiology and Co-Director of the Division of Interventional Radiology at Thomas Jefferson University in Philadelphia, Pennsylvania.

According to Inari, PEERLESS is a prospective, RCT that is planned to randomize 550 patients at up to 60 centers in the United States and Europe. The trial will also randomize up to 150 patients in a registry cohort that cannot be randomized because of an absolute contraindication to thrombolytics.

The FlowTriever system is 510(k)-cleared by FDA and CE Mark approved for the treatment of pulmonary embolism and clot in transit in the right atrium.