Inari Medical Announces First Patient Enrolled in the PEERLESS Trial, a Randomized Controlled Trial Evaluating Outcomes of the FlowTriever® System in Pulmonary Embolism Patients
IRVINE, Calif., Feb. 15, 2022 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) today announced that the first patient has been enrolled in PEERLESS, a prospective, randomized controlled trial (“RCT”) comparing the outcomes of patients with intermediate-high risk pulmonary embolism (“PE”) treated with the FlowTriever system versus catheter-directed thrombolysis (“CDT”).
The first PEERLESS patient was enrolled by Dr. Amir Kaki, Interventional Cardiologist, Ascension St. John Hospital in Michigan. PEERLESS will randomize 550 patients and will also enroll up to 150 patients in a registry cohort for patients who cannot be randomized due to an absolute contraindication to thrombolytics. The trial will include up to 60 centers in the United States and Europe.
“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 ICU 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.”
“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,” said Global Co-Principal Investigator, Dr. Carin Gonsalves, Professor of Radiology and Co-Director of the Division of Interventional Radiology at Thomas Jefferson University in Philadelphia, PA. “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.”
“The treatment of PE is undergoing a transformation. We have been thrilled by the desire of physicians to move this field forward and generate high-quality data through PEERLESS,” said Dr. Thomas Tu, Inari’s Chief Medical Officer. “We are grateful for the collaboration and dedication of our clinical trial investigators on this first of many PE studies to come.”
About Inari Medical, Inc.
Inari Medical, Inc. is a medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases. Inari has developed two minimally invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purpose-built its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE: deep vein thrombosis and pulmonary embolism. The ClotTriever system is 510(k)-cleared by FDA and CE Mark approved for the treatment of deep vein thrombosis. 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.