|AtriCure Announces the First Patient Enrolled in the FROST Cryoanalgesia Study|
FROST will evaluate cryoablation of peripheral nerves for the temporary management of post-operative pain
The design of the trial is a prospective, 3:1 randomized trial including a total of up to 100 patients. The randomization will include up to 75 patients in the treatment arm (intraoperative cryoablation plus SOC), and up to 25 patients in the control arm (SOC alone). The study will include patients undergoing unilateral thoracotomy cardiac procedures and will evaluate pain scores and lung function recovery during hospital stay.
“FROST is the first prospective study of the cryoICE system evaluating its ability to manage post-operative pain, enabling faster and more complete patient recovery,” said Michael Carrel, President and Chief Executive Officer of AtriCure “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.”
The primary objective of the study is to demonstrate that intraoperative intercostal cryoanalgesia in conjunction with SOC provides improved analgesic efficacy and faster, more complete recovery in patients undergoing unilateral thoracotomy cardiac procedures as compared to current SOC. Additional endpoints, such as ICU length of stay, total hospital length of stay, opioid consumption, and long-term neurologic recovery will be gathered.
“In my experience, cryoanalgesia appears to result in improved pain
management,” said Dr
“I have continued to see the benefits of cryoanalgesia therapies in conjunction with minimally invasive mitral valve surgery,” stated Dr. Francis Shannon, cardiothoracic surgeon, Beaumont Health System. “The benefit for patients is quite significant, and I look forward to developing further evidence through participation in the FROST study.”
Participating centers in the study are the
“Today’s pain management options offer relief while patients are
hospitalized, but do little to address pain post-discharge,” said Dr.
This press release contains “forward-looking statements”--that is, statements related to future events that by their nature address matters that are uncertain. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, visit http://www.atricure.com/fls as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. We do not undertake to update our forward-looking statements. This document also includes forward-looking projected financial information that is based on current estimates and forecasts. Actual results could differ materially.