The FDA approved Nevro's ($NVRO) novel spinal cord stimulation system Friday, saying it is the only device in the class that does not produce a tingling sensation known as paresthesia.
"Since some patients don't like the paresthesia associated with traditional SCS, this device offers another treatment option," said Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA's device arm (CDRH), in a statement.
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| Senza spinal cord stimulation system--Courtesy of Nevro |
Nevro's Senza System fights chronic pain in the back and legs without causing the side effect by delivering high frequency stimulation at 10 kilohertz and low amplitudes, the FDA says.
In addition, the device is the only spinal cord stimulation system approved with superiority labeling due to a 198-person, randomized, controlled clinical trial showing Senza patients had better outcomes than those on traditional stimulators, as measured by response rates, pain relief and functional outcomes.
"My fellow investigators and I have eagerly awaited the approval of the Senza SCS system," said the trial's lead investigator, Dr. Leonardo Kapural of Wake Forest University Baptist Medical Center, in a statement. "The results of the study showed that HF10 therapy provides better pain relief and nearly twice the response rate of traditional SCS, representing a tangible advance in chronic pain management. HF10 therapy will allow me to help more patients in my practice by addressing back pain in addition to leg pain. And, with HF10 therapy I can for the first time focus on providing pain relief to my patients instead of managing paresthesia, which is a paradigm shift for my pain practice."
Nevro pointed to two other firsts in its release, saying the Senza is the only spinal cord stimulator approved without restrictions on driving while receiving therapy and the only one to receive labeling for 3 Tesla conditional MRI compatibility.
Prior to minimally invasive implantation of the Senza, patients are supposed to test it outside the body for one to two weeks, the FDA says. The device consists of leads inserted into the back that connect to a pulse generator, which is implanted in the patient's buttocks region or abdomen. The pulse generator is programmed prior to implantation, and controlled externally via remote following the procedure.
Nevro received an approvable letter from the FDA in January, meaning the agency was ready to grant the Senza its blessings pending satisfactory completion of an audit of the company's manufacturing facilities and finalization of product labeling.
On the back of the commercialization of Senza in the European Union and Australia, achieved over the past 5 years, Nevro reported revenues of $9.7 million in Q1 2015, up 70% at constant currencies and 45% as reported. But the company still lost $12.3 million during the quarter, according to today's just-released earnings report.
"I am pleased that adoption of HF10 therapy has continued at a strong pace in the first quarter in European Union and Australian markets," said Michael DeMane, CEO of Nevro in a statement. "As a result, more patients in need are afforded the benefits of Nevro's best-in-class spinal cord stimulation technology. Now, with PMA approval and the first FDA SCS superiority label, these meaningful patient benefits will for the first time be made available to U.S. chronic pain patients."
The company is fielding a sales force of 30 to 40 reps as it commences commercialization of Senza in the U.S.
- here's FDA announcement
- read the release
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