Pacira BioSciences, Inc. announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market a new Smart Tip designed to access the medial branch nerves to manage chronic low back pain. The ioveraº system is an innovative, FDA-cleared, drug-free treatment that relieves pain via cryoneurolysis?a process whereby focused cold therapy is applied to a targeted nerve, temporarily interrupting its ability to transmit pain signals. Pain relief is typically experienced immediately after treatment, with the effects lasting for months as the nerve gradually regenerates.

To date, the ioveraº portfolio has consisted of either a three-pronged Smart Tip featuring 8.5-mm long 27-gauge needles to treat superficial nerves or a single, 90-mm long, 20-guage Smart Tip ideally suited to treat deeper nerves. It is most commonly used to treat knee pain, but frequently used to manage pain in the hip, shoulder, chest, foot and ankle, and more. Now, this new, 25-gauge 180-mm Smart Tip will allow for the treatment of deeper nerves, such as the medial branch nerve and is specifically designed so that it can relieve chronic low back pain associated with facet mediated pain.

This longer-needle Smart Tip is uniquely designed for use through a cannula or introducer, providing the ability for ice ball formation at deeper peripheral nerves. Chronic low back pain remains a pervasive health challenge in the United States: Back pain is the leading cause of disability nationwide. It is also the most common reason for extended work absences.

Chronic back pain is the number one indication for opioid prescriptions, often leading to dependency and abuse. Annually, 28 to 30 million Americans seek treatment for chronic back pain, yet only 2 to 3 million undergo interventional procedures. With the introduction of this new iovera° Smart Tip, Pacira aims to address these gaps and elevate the standard of care.

This FDA-cleared innovation offers a compelling alternative to conventional treatments such as radiofrequency ablation (RFA) ablation, which has substantial limitations. With RFA, patients may not get the effects of pain relief until 1-2 weeks after treatment, further the intense heat can damage surrounding tissue and blood vessels, and tissue damage may lead to painful neuritis (inflammation in the nerves). A single-center randomized pilot study conducted by Interventional Pain Management and Physical Medicine and Rehabilitation (PM&R) Specialist Martin Ferrillo, DO, of Albany and Saratoga Centers for Pain Management, compared iovera° cryoneurolysis to RFA for facet-mediated chronic back pain.

The findings underscore the significant advantages of the iovera° system: Patients treated with iovera° reported pain scores that were more than 2 points lower at 180 and 360 days compared to those treated with RFA on the 0-10 NRS Pain scale. At 360 days, patients in the iovera° group showed statistically and clinically significant improvements in functional outcomes, as evidenced by average Oswestry Disability Index (ODI) scores improving from moderate disability to minimal disability. More iovera° patients expressed satisfaction with their pain management compared to those receiving RFA.

No serious adverse events were observed over the course of the study.