Upload
gabriella-darnall
View
219
Download
3
Tags:
Embed Size (px)
Citation preview
London Bridge Hospital Orientation
January 2011COMPANY CONFIDENTIALNOT FOR DISTRIBUTION
What Is SCS?
Nevro Confidential
Spinal cord stimulation (SCS) is a reversible and minimally invasive therapy for reducing chronic leg pain
Typical indications include patients with : Failed Back Surgery Syndrome (FBSS) Intractable neuropathic leg pain Complex Regional Pain Syndrome (CRPS)
SCS has been in use for more than 40 years to treat patients with chronic, neuropathic pain
Current players: Medtronic, St Jude Medical and Boston Scientific
What Is SCS?
Nevro Confidential
SCS procedure involves: percutaneous or surgical implantation of leads into the epidural
space leads are connected to an implantable pulse generator (IPG)
Electrical pulses delivered to the spinal cord alleviate pain
SCS trial to permanent implant process:
“Temporary trial”
Percutaneous lead insertion Intra-operative testing &
programming Therapy at home for several days/weeks
“Permanent implant” IPG implanted & connected to lead
If >50% pain relief
Conventional SCS’s Unmet Needs
Paresthesia-dependent masking of pain Paresthesia (an altered sensation) is felt as an electrical
“buzzing” or tingling sensation in the extremities The position of the leads and the electrical parameters
programmed determine the location and intensity of the paresthesia
Paresthesia commonly induces a shocking sensation as body position changes
71% of SCS patients surveyed found paresthesia uncomfortable, sometimes worse than the pain itself
4
Nevro Confidential
Conventional SCS’s Unmet Needs
Failure to adequately treat low back pain Attempted and failed to achieve consistent and durable back
pain relief: Medtronic St. Jude Boston Scientific
Leg pain relief commonly unmasks underlying back pain post-SCS
Attempts to relieve back pain commonly over-stimulate the legs
Unresolved back is a major opportunity—NANS 2010 survey respondents indicated that: 43% of their current SCS patients complained of unresolved back pain SCS procedure volume would grow 110% if they had access to a device
that allowed them to effectively treat low back pain
5
Nevro Confidential
Conventional SCS’s Unmet Needs
Inefficient use of theatre and physician time Intra-operative testing involves an iterative approach
with poor guidelines for lead placement and optimal parameter selection
Patient must be awakened in the operating room to provide feedback to the physician regarding coverage of painful regions with paresthesia
6
Nevro Confidential
Conventional SCS’s Unmet Needs
Continued need for opiates to provide relief for unaddressed (back) pain 65% of SCS study candidates were on opiates at baseline Continued management of narcotic analgesics is an
additional burden for physician and patient with significant concerns regarding addiction
7
Nevro Confidential
Nevro System Benefits
Relief of leg and back pain Intra-operative procedure simplicity Anatomic versus physiologic lead placement Reduced physician management burden No paresthesia or shocking Limited return office visits required Reduced device complexity for patients Reduced need for opiates and opiate
management
8
Nevro Confidential
Nevro Clinical Trials
US Feasibility Study Evaluation during temporary trial considering:
Patient preference for Nevro versus Conventional SCS Presence of paresthesia, jolting and shocking Short-term pain relief
International Multi-center Trial Evaluation of Nevro’s permanently implantable SCS
system considering: The long-term, sustainable relief of leg and back pain Functional improvements reported by patients Opiate use post-implant
9
Nevro Confidential
US Feasibility Trial ResultsPain Relief (10 point Visual Analog Score)
10
P < 0.001P < 0.001
Nevro Confidential
Nevro provides better pain relief (77% vs 56%)
US Feasibility Trial ResultsPain Relief
11
20 out of 2414 out of 24
Nevro Confidential
More positive
screenings result in
more implants
US Feasibility Trial ResultsPatient Preference
21 out of 24 patients chose Nevro therapy over Conventional SCS
12
Nevro patients:
do not experience paresthesia
do not need to adjust therapy with changes in body position
are not shocked during body position changes
Prefer Nevro
88% of Patients Prefer Nevro Therapy
(N=24)
Nevro Confidential
International Multi-center Trial ResultsLong-term Data Comparison
13
Nevro versus PROCESS* Trial Results
(1)Pain relief is measured by difference in VAS.(2)Functional Improvement is measured by reduction in Oswestry Disability Index score. 0 = no disability, 100= extreme disability. Higher
reduction in score represents better functional improvement. (3)Kumar, 2007, PAIN. Pain relief data are extrapolated from graphs in the article.Nevro Confidential
3x better relief of
back pain
Nearly 2x better leg pain relief
50% improvement
in function
3x less opiate use
*most credible Conventional SCS study to date
International Multi-center Trial ResultsNevro: Succeeding Where Conventional SCS Has Failed
14
87%Success
Rate in SCS Failures!
Nevro Confidential
Other Results and Benefits
No reported paresthesia Less programming for doctor and patient
No movement-dependent jolting/shocking Fewer patient complaints and office visits
Improved sleep At 6 months, sleep disturbance reduced by 82%
Eliminated (83%) or reduced opiate use at 6 months Less narcotic management and concern over addiction
Shorter procedure time More time to enjoy life or perform more procedures!
15
Nevro Confidential
Nevro Corp Profile
Co-Founded by Mayo Clinic Licensed technology and know how $50M invested to date by leading healthcare investors
CE Mark received May 2010
International thought leader support Jean-Pierre VanBuyten, MD-Belgium Adnan Al-Kaisy, MD-UK Jaimie Henderson, MD-Stanford University Others
Plenary session presentations approved or planned at: North American Neuromodulation Society Annual Meeting Dec 2010 American Academy of Pain Management Meeting March 2011 International Neuromodulation Society Meeting May 2011
16
Nevro Confidential