Pacira BioSciences has received US Food and Drug Administration (FDA) clearance for its new iovera° Smart Tip, designed to manage chronic low back pain.
The ioveraº device is a handheld, drug-free treatment intended to provide immediate, long-lasting pain relief by delivering precise, controlled doses of cold therapy to targeted nerves.
It is engineered to access medial branch nerves and manage back pain.
Using a cryoneurolysis process, the device applies focused cold therapy to target nerves and interrupts their ability to transmit pain signals. Pain relief is typically immediate, with effects lasting for months as the nerve regenerates, Pacira BioSciences said.
The ioveraº portfolio already includes a three-pronged Smart Tip with 8.5-mm, 27-gauge needles for superficial nerve treatment, as well as a single, 90-mm, 20-gauge Smart Tip for deeper nerves. These devices are used to treat knee pain and manage hip, shoulder, chest, foot, ankle, and more pain.
The new 25-gauge, 180-mm Smart Tip is designed for treating deeper nerves, including the medial branch nerve, to relieve chronic low back pain caused by facet-mediated pain.
Its longer needle is specifically engineered for use through a cannula or introducer, enabling ice ball formation at deeper peripheral nerves.
With the new iovera° Smart Tip, Pacira BioSciences aims to enhance patient care and address gaps in existing treatments.
This FDA-cleared innovation provides a strong alternative to radiofrequency ablation (RFA), which has key limitations.
The health solutions provider said iovera° delivers immediate pain relief without the delayed effects of one-two weeks, unlike RFA. Additionally, RFA’s intense heat can harm surrounding tissue and blood vessels, potentially causing painful neuritis.
Pacira BioSciences chief medical officer Jonathan Slonin said: “The FDA clearance of this new iovera° Smart Tip is a pivotal step forward, offering patients an innovative, drug-free solution that delivers meaningful and lasting pain relief.
“This achievement reflects our dedication to improving quality of life for the millions of Americans living with chronic back pain.”
A pilot study comparing iovera° cryoneurolysis to RFA for facet-mediated chronic back pain showed iovera° significantly reduced pain scores, improved functional outcomes, and increased patient satisfaction, with no serious adverse events.
Pacira BioSciences offers non-opioid pain therapies, including EXPAREL and ZILRETTA. These treatments provide long-lasting pain relief for postsurgical pain, osteoarthritis, and more.
The health solutions provider is also developing PCRX-201, a gene therapy for osteoarthritis.
