Utilizing the P-STIM Device

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History

• P-STIM: Peripheral NeuroStimulator • History

• Invented in Austria by Dr J.C. Szeles • Vascular Surgeon

• Discovered Multiple Uses (Pain and Perfusion)

• FDA Cleared in 2006 as Auricular ElectroStimulator • Recent studies show PENS (Percutaneous Electrical

(Vagus) Nerve Stimulator)

• FDA Cleared for symptom relief of Acute & Chronic Pain

• Product Specifications

– 3 Leads (Needles)

– 3hr cycle (ON)/3hr rest (OFF)

– Battery operated – lasts 3-4 days

Device Specifications

• Back Pain • Cervical Pain • Sciatica • Pre & Post Operative Pain Mgmt • Migraines/Constant Headaches • Complex Regional Pain Syndrome • Arthritic and Joint Pain • Diabetic Neuropathy • Depression • Insomnia • Fibromyalgia • Shingles

FDA Cleared Indications

• No incision required for application

• No anesthesia

• No radiation exposure

• Non-Narcotic

• Non-Addictive/Drug-Free

• No side effects

• No organ damage

• Performed in 15 minutes

Key Advantages

How does the P-STIM work?

Percutaneous Application of NeuroStimulator • Leads/Needles access the branch of vagus nerve • Stimulates parasympathetic systems • Causes vasodilation • Anti-inflammatory effect: decreased CRP and ESR • Enables the body to release endogenous endorphine • This process balances the ANS which controls pain and

perfusion

Mechanism of Action

Vagus nerve, the tenth cranial nerve, arises from the medulla and carries both afferent and efferent fibers. Modulating effects on the central pain network in the hypothalamus and the limbic system have been proposed Activation of endogenous opioids (encephalins) in the substantia gelatinosa of spinal grey matter resulting in inhibition of pain signals to the brain

Chronic Low Back Pain Study

J. Constantin Széles

P-STIM Auricular Acupuncture

Thermographic Recording of Patient with Peripheral Arterial Disease under P-Stim

Peripheral vascular disease (PVD): Walking Distance after P-STIM

Diabetic Foot Syndrome P-STIM (with Vivostat)

J. C.

Széles

Diabetic Foot Syndrome

P-STIM

(after 3 months)

Ear Anatomy

• P-Stim Device

• Protective Cap

• 3 Sterile Needles

• 3 Oval Adhesives

• Multi-point Stylus Replacement Cap

• Alcohol Prep Pad

• Tagaderm Adhesive Tape

P-STIM Packaging Components

• Tac Gel Adhesive

• Forceps

• Cotton Tip Applicators

• Multi-point Stylus

Additional Materials Needed

• Stylus – activate battery, sterilize tip, replace cap

• Activate Device by removing tape & pressing batteries into place

• Attach protective cover

• Test device with Stylus pen (listen for background ticking)

• Attach leads to titanium needles

• Remove sticker from back of device and place it on charge sheet in “sticker window”

• Sterilize neck and auricular region

• Apply Tac Gel to back of the device

• Place device behind ear & hold in place for 60 seconds

P-STIM Placement Process (1 of 2)

• Use Stylus to locate peripheral nerves

• Place the percutaneous titanium needles using forceps

• Secure needles with oval adhesives (provided in pkg)

• Tape down the wire behind patient’s ear

• Secure device, leads and electrodes with Tagaderm tape (provided in pkg)

Placement Process (2 of 2)

• The device cycles an electrical current in 3 hour intervals (3 hours on / 3 hours off)

• Each P-STIM cycle lasts 3-4 days

• After the 4th day, the device is removed by the patient

• Subsequent treatments are recommended after global period of 10 days

How long does each P-STIM treatment last?

• Each patient is different

• Acute conditions 3-6

• Chronic condistions 9-15

• Dr. Szeles recommends 9-15 treatments

How many P-STIM Treatments?

• Patients will feel a mild tapping or pulsing at the treatment points. The intensity depends on the patient. It is generally very mild and will diminish over the 4 days of the treatment.

• Many patients feel a sense of euphoria and relaxation during the first few treatments while others may not.

• Most patients experience enhanced and more restful sleep

What will I feel during the Procedure?

• Europe - None

• US - Pacemaker and Pregnancy

Contraindications

• If the P-STIM device gets wet, it may simply stop functioning.

• If this happens, patient should return to clinic for a replacement device.

Keep the Device Dry

• Understanding that every patient reacts differently, it is not uncommon for the effects to last for months or years and in some cases much longer given the normal course of treatment is followed.

• If or when pain does return the next course of treatment is normally an abbreviated one.

How long does the effects last after taking off the P-STIM device?

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