New device targets medial branch nerves with cryoneurolysis, offering immediate and long-lasting relief.
Pacira BioSciences has received FDA 510(k) clearance for its iovera° Smart Tip, designed to manage chronic low back pain through cryoneurolysis. This innovative tool targets medial branch nerves, providing immediate, drug-free relief lasting several months.
Advanced Pain Management
The 25-gauge, 180-mm Smart Tip enables precise treatment of deeper nerves linked to facet-mediated back pain. Unlike radiofrequency ablation (RFA), the iovera° system delivers immediate results without tissue damage, reducing recovery times and risks.
Study Highlights
A pilot study comparing iovera° cryoneurolysis to RFA showed:
- Faster Pain Relief: iovera° patients experienced significantly lower pain scores at 180 and 360 days.
- Improved Functionality: Disability scores improved from moderate to minimal for iovera° patients.
- High Patient Satisfaction: Greater satisfaction was reported compared to RFA treatments.
Addressing a National Challenge
With chronic back pain impacting up to 30 million Americans annually, the iovera° Smart Tip provides a minimally invasive, opioid-free alternative to conventional treatments.
Pacira’s FDA-cleared innovation expands the capabilities of its iovera° system, offering hope for patients seeking effective and lasting relief.
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