Current regulatory news

FDA APPROVALS

The U.S. Food and Drug Administration (FDA) has approved an expanded indication for Boston Scientific’s WaveWriter SCS Systems for the treatment of chronic low back and leg pain in people without prior back surgery, commonly referred to as non-surgical back pain (NSBP).

First-line treatment for people with chronic back pain is usually limited to conventional medical management such as physical therapy and medication, which aren’t effective for many people. Effective chronic pain management may lead to improved quality of life and reduced opioid use.

The expanded indication is backed by positive one-year data from the SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery (SOLIS) randomized control trial, which met its primary endpoint (≥50% reduction in pain) at three-month interval and demonstrates the WaveWriter SCS Systems provide significant and sustained pain relief. Followed out to one year, 84% of patients treated with the WaveWriter Systems reported significant pain relief of ≥50% and sustained improvement in their ability to participate in activities of daily living, with a mean 25-point improvement in disability as measured by the Oswestry Disability Index.

Neuralace Medical has received FDA clearance for Axon Therapy, a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for chronic painful diabetic neuropathy (PDN). An mPNS session is painless and lasts for 13.5 minutes, using magnetic pulses to provide relief.

“The FDA clearance of Axon Therapy is a monumental step forward in the treatment of PDN,” says Keith Warner, CEO of Neuralace Medical. “This first-of-its-kind, non-invasive solution embodies our commitment to innovative, patient-centered care, offering effective pain relief without the drawbacks of conventional, more invasive treatments.”

A recent double-blind Multi-Center Randomized Controlled Trial (RCT) involving 71 patients demonstrated significant improvement in subjects treated with Axon Therapy.

Spirair has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SeptAlign system, a minimally invasive treatment for nasal septal deviation (NSD). This condition is one of the most common causes of nasal airway obstruction, making breathing through the nose difficult.

Treatment for NSD has been limited to medication for symptom relief or invasive surgical procedures such as traditional septoplasty. The latter can result in long recovery times of two weeks or more.

“Demand for minimally invasive treatment options has been steadily rising across healthcare in recent years, but there have been few such options for people suffering from symptomatic NSD,” says Benjamin Bishop, CEO of Spirair. “SeptAlign is a minimally invasive treatment that can be safely and conveniently performed under local anesthesia and enables ENTs to expand their treatment options for more patients.”

In August 2023, Spirair received FDA approval for the SeptAlign bioabsorbable implant, which is inserted in the cartilage at the front of the nose and holds the straightened septum under tension. The implant dissolves after six months, at which point the cartilage retains its new shape. The treatment has been clinically demonstrated to straighten minor cartilaginous septal deviation.