AtriCure (NSDQ:ATRC) said today it launched and enrolled the 1st patient in the Frost trial which aims to examine the use of its CryoIce system designed for the cryoablation of peripheral nerves for the temporary management of post-operative pain.
The trial is slated to enroll up to 100 patients to explore the use of cryoanalgesia in addition to standard of care pain management compared against standard of care pain management alone, the West Chester, Ohio-based company said.
“Frost is the 1st prospective study of the cryoICE system evaluating its ability to manage post-operative pain, enabling faster and more complete patient recovery. Since we launched our temporary pain management indication under 510(k) clearance in early 2015, adoption of this therapy has been solid, as surgeons see the positive effects on their patients. This study is designed to provide further clinical and scientific evidence,” CEO Michael Carrel said in a press release.
The study plans to include patients undergoing unilateral thoracotomy cardiac procedures, and will evaluate pain scores and lung function recovery during hospital stays post-procedure, Atricure said.
The primary objective of the study is to analyze whether intercostal cryoanalgesia with the CryoIce device along with standard of care paint management provides improved analgesic efficacy and a quicker, more complete recovery for patients undergoing unilateral thoracotomy cardiac procedures when compared to standard pain management.
“Today’s pain management options offer relief while patients are hospitalized, but do little to address pain post-discharge. We have seen cryoanalgesia control pain and improve recovery post-operatively,” coordinating investigator Dr. Wei Lau of the Oakland University William Beaumont School of Medicine said in a prepared statement.
Endpoints include ICU length of stay, total length of stay, opioid consumption and long-term neurologic recovery, AtriCure said.
Centers participating in the study include the William Beaumont Hospital, the University of Michigan Medical center and the Cleveland Clinic Foundation.
“I have continued to see the benefits of cryoanalgesia therapies in conjunction with minimally invasive mitral valve surgery. The benefit for patients is quite significant, and I look forward to developing further evidence through participation in the Frost study,” coordinating investigator Dr. Francis Shannon of Beaumont Health System said in prepared remarks.
In April, Atricure said it won FDA 510(k) clearance for its CryoForm cryoablation probe designed for use in cardiac ablation procedures, such as atrial fibrillation.
The CryoForm is designed with the ability to remove heat and actively defrost, which allows the operator to safely detach the device while maintaining internal tissue’s frozen state, AtriCure said.
The company said the probe allows for increased flexibility and easier manipulation to allow for better conformation in challenging anatomies.
