1. North America Neuromodulation Society I3 Session
Creating a Device Around Headache
Benjamin Pless, CEO
Autonomic Technologies, Inc.
North America Neuromodulation Society I3 Session
Las Vegas, December 2012
Dec 6, 2012
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2. 2007(March): The beginning
Cleveland Clinic presentation to KPCB of autonomic patents to control a wide range of disorders
Headache
Vascular
Cardiac
Pulmonary
Renal
Dec 6, 2012
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3. SPG is a known therapeutic target to treat headache
SPG interventions have a long history in the treatment of Migraine and Cluster Headache
Anesthetic trans-nasal topical blocks
Drug injection blocks
Pulsed RF and ablative blocks
Surgical procedures including gamma knife
Acute interventions have been reported sometimes to provide weeks of sustained pain relief
Local Anesthetic Topical Blocks
Intranasal Approach
Local Drug Injection Blocks
Intranasal
Infra-Zygomatic
Supra-Zygomatic
Palatine
Ablative Blocks
Radio Frequency Lesions
Pulsed RF Lesions
Gamma Knife Lesions
Cryosurgical Lesions
Dec 6, 2012
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4. Autonomic Technologies Not For Distribution
Acute SPG Stimulation
Early Proof of Concept research at the Cleveland Clinic by physician inventors demonstrating ability of stimulation to stop cluster headaches
Dec 6, 2012
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5. Autonomic Technologies Not For Distribution
Dec 6, 2012
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6. Sphenopalatine Ganglion (aka Pterygopalatine Ganglion) – a closer look
R.L. Drake, Grays Anatomy for Students, 2005
Dec 6, 2012
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7. Autonomic Technologies Not For Distribution
Dec 6, 2012
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8. ATI Product Considerations
Good cosmesis
majority of patients are women
Minimally invasive implant
Difficult surgery would reduce acceptability
Simple and easy explant
“no harm, no foul” lowers barriers to acceptance
Dec 6, 2012
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9. Prior Neurostimulator Paradigm
Dec 6, 2012
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10. Early ATI Product Concept
Dec 6, 2012
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11. Patient Experiences of Tunneling
Dec 6, 2012
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12. Surgical Retreat August 2008
ATI dissatisfaction with invasiveness of approach
Included variety of
Neurosurgeons
ENTs
Plastic surgeons
CMF
Dec 6, 2012
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13. Autonomic Technologies Not For Distribution
Dec 6, 2012
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14. Gingival Buccal Approach to the SPG
Adopted by ATI
Developed by: Dr. Frank Papay,
Cleveland Clinic, Cleveland Ohio
Dec 6, 2012
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15. New ATI Neurostimulator Concept
No battery
Patient activated
Stimulating probe
neurostimulator
Fixation bracket
Dec 6, 2012
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16. Autonomic Technologies Not For Distribution
Upper Lip
Mucosa Incision
The procedure begins by doing a submucosal injection of a vasoconstrictor and local anesthesic. An 1-2 cm incision is made approximately 3 to 5 mm superior to the mucogingival junction.
Dec 6, 2012
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Mucosa
Periosteal elevators are used to elevate the tissue in the subperiosteal plane. Dissect the tissue until the inferior aspect of the zygomaticomaxillary buttress area is exposed, also called the zygomatic process of the maxilla.
Dec 6, 2012
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18. Autonomic Technologies Not For Distribution
ATI introducer
The proprietary ATI introducer is then inserted subperiosteally behind the zygomaticomaxillary buttress, and advanced on the posterior side of the maxillary sinus to the pterygopalatine fossa.
Dec 6, 2012
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19. Autonomic Technologies Not For Distribution
ATI neurostimulator
The neurostimulator is then placed in the PPF either by using the introducer as a guide, and sliding the neurostimulator probe between the bone and introducer, or by removing the introducer and placing the neurostimulator probe into the dissection path created by the introducer.
Dec 6, 2012
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20. ATI neurostimulator Implantation
Neurostimulator lead in the pterygopalatine fossa stimulates the sphenopalatine ganglion (SPG)
Neurostimulator lead within the pterygopalatine fossa
Dec 6, 2012
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21. Autonomic Technologies SPG Stimulator for Headache
Implantable Neurostimulator
Miniaturized
Minimally invasive
CE Marked
Investigational use only in the US
Simple therapy controls: on/off and up/down
Wirelessly powers and controls Neurostimulator
Rechargeable battery with USB connector for charging
Wirelessly powers/activates Neurostimulator
Patient control of stimulation and amplitude
Headache Diary
Pain level
Autonomic symptoms
Rescue medication use
Wireless data transmission
Use data
Headache diary responses
On-demand,
patient-controlled therapy
Dec 6, 2012
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22. Acute Response to SPG Stimulation
Dec 6, 2012
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23. Special Thanks to Physician Collaborators
Frank Papay
Stew Tepper
Ali Rezai
Samer Narouz
Mehdi Ansarinia
Joseph Roberson
Michael Stanton-Hicks
Peter Goadsby
Richard Lipton
Jean Schoenen
Rigmor Jensen
Arne May
Soren Hillerup
Stephen Silberstein
Miguel Lainez
…and many more!!!
Dec 6, 2012
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24. Autonomic Technologies Not For Distribution
Thank You!
Dec 6, 2012
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