Pacira BioSciences, a leading provider of innovative non-opioid pain management solutions, has announced the approval of a new Smart Tip by the U.S. Food and Drug Administration (FDA). This latest development is designed to access medial branch nerves to address chronic low back pain effectively.

The iovera° system employs cryoneurolysis, a method that uses targeted cold therapy to temporarily halt nerve signals that transmit pain. This approach provides immediate pain relief, with effects lasting several months as the nerve regenerates.

Previously, the iovera° portfolio included two Smart Tip options: a three-pronged model with 8.5-mm, 27-gauge needles for superficial nerves and a single 90-mm, 20-gauge needle for deeper nerve applications. These tools have been widely used for knee pain and other conditions affecting the hip, shoulder, chest, foot, and ankle.

The newly cleared 25-gauge, 180-mm Smart Tip extends the system’s capability by enabling treatment of deeper nerves, such as the medial branch nerve. It is particularly suited for managing chronic low back pain caused by facet-mediated issues. This longer needle design works through a cannula or introducer, allowing ice ball formation at deep peripheral nerves to enhance treatment precision.

Chronic low back pain is a significant health issue in the United States. It is the leading cause of disability, the primary reason for long-term work absences, and the most common condition leading to opioid prescriptions, which can result in dependency or abuse. Approximately 28 to 30 million Americans seek treatment for chronic back pain each year, but only a small percentage undergo interventional procedures.

The new iovera° Smart Tip provides a viable alternative to existing treatments such as radiofrequency ablation (RFA), which can delay pain relief by one to two weeks and may cause tissue damage, blood vessel injury, or painful neuritis.

A single-centre pilot study conducted by an interventional pain management specialist compared the effectiveness of iovera° cryoneurolysis with RFA for facet-mediated chronic back pain. The results showed that iovera° patients experienced greater pain reduction, improved functional outcomes, and higher satisfaction levels over a 12-month period. Importantly, no serious adverse events were reported.

This advancement highlights Pacira’s commitment to addressing the gaps in chronic pain management by offering a drug-free and minimally invasive option that improves patient outcomes. The iovera° Smart Tip has the potential to enhance the quality of life for millions of individuals living with chronic back pain.



Source: globenewswire.com

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