Nevro Corp. (NYSE:NVRO) said yesterday that it won CE Mark approval in the European Union for the next generation of its spinal cord stimulator for treating chronic pain.
Redwood City, Calif-based Nevro said its Senza II SCS is smaller than its predecessor Senza device, which won an FDA nod in May 2015. Both devices are designed to deliver high-frequency electrical impulses of up to 10,000Hz to the spinal cord to avoid the tingling sensation known as paresthesia that bothers some SCS patients.
“Senza II is a step forward that represents our company’s commitment to continuously advancing our product portfolio,” president & CEO Rami Elghandour said in prepared remarks. “The smaller, refined footprint delivers the unparalleled performance of our current Senza system and is backed by the same best-in-class clinical evidence that you’ve come to expect from Nevro and HF10 therapy. We look forward to initiating a controlled rollout in Europe.”
“My colleagues and I have eagerly awaited the approval of the Senza II SCS system,” added Dr. Adnan Al-Kaisy of London’s Guy’s and St Thomas’ Hospital. “The reduced size and optimized design of the Senza II [implantable pulse generator] allow for greater patient comfort and placement options. This is further advancement of a device that seven years ago revolutionized treatment for chronic back and pain sufferers by providing profound and paresthesia-free pain relief.”
Earlier this month Nevro won MR-conditional CE Mark approval for the original Senza implant.
NVRO shares closed down -1.1% at $74.82 apiece yesterday and were down a penny from that this morning in pre-market trading.