REDWOOD CITY, Calif.,
Jan. 8, 2018 /PRNewswire/
-- Nevro Corp. (NYSE:NVRO), a global medical device company
that is providing innovative evidence-based solutions for the
treatment of chronic pain, today announced that it has received FDA
approval for its next-generation Senza II Spinal Cord Stimulation
(SCS) System delivering HF10 therapy. The Senza II system offers
the superior outcomes and clinical advantages of HF10 therapy
through a smaller and more refined footprint while maintaining the
performance and durability of the current Implantable Pulse
Generator (IPG).
"My colleagues and I are excited about the approval of the Senza
II SCS system," said Dr. Tom
Simopoulos, Director of Pain Medicine and Co-Director of the
Spine Center at the Beth Israel Deaconess Medical Center (an
affiliate of the Harvard Medical
School) in Boston, MA. "The
reduced size and optimized design of the Senza II IPG allow for
greater patient comfort and placement options. Most importantly, it
delivers HF10 therapy, a non-opioid treatment option that provides
profound and paresthesia-free pain relief for patients."
"We are pleased to have received FDA approval for Senza II so
quickly after our recent CE Mark clearance. Senza II is a step
forward that represents our company's commitment to continuously
advancing our product portfolio," said Rami
Elghandour, President and CEO of Nevro. "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.
The initial product feedback from our European customers has been
excellent, and we look forward to launching Senza II in
the United States."
About the Senza II System and HF10 Therapy
The Senza
II system delivers Nevro's proprietary HF10 therapy, an SCS therapy
that provides electrical pulses to the spinal cord to alleviate
pain. The electrical pulses are delivered by small electrodes on
leads that are placed near the spinal cord and are connected to a
compact, battery-powered generator implanted under the skin. HF10
therapy is the only SCS therapy indicated to provide pain relief
without paresthesia (a stimulation-induced sensation, such as
tingling or buzzing, which is the basis of traditional SCS) and is
also the first SCS therapy to demonstrate superiority to
traditional SCS for back and leg pain in a comparative pivotal
study. Nevro's innovations in SCS, including the Senza® and Senza
II™ systems and HF10™ therapy, are covered by more than 140 issued
U.S. and international patents.
About Nevro
Headquartered in Redwood City, California, Nevro is a global
medical device company focused on providing innovative products
that improve the quality of life of patients suffering from
debilitating chronic pain. Nevro has developed and commercialized
the SENZA® spinal cord stimulation (SCS) system, an evidence-based,
non-pharmacologic neuromodulation platform for the treatment of
chronic pain. The SENZA® system is the only SCS system that
delivers Nevro's proprietary HF10™ therapy. Senza, Senza II, HF10,
Nevro and the Nevro logo are trademarks of Nevro.
Investor Relations Contact:
Nevro Investor
Relations
Katherine Bock
(650) 433-3247
ir@nevro.com
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SOURCE Nevro Corp.