Peripheral Artery Disease

Shock wave therapy for Peripheral Artery Disease associated with intermittent claudication, suggested treatment protocols.

Intended use
Shock wave therapy is intended for treatment of chronic peripheral ischemia in lower extremities.

• Confirmed diagnosis of PAD
)• Ankle-brachial pressure index (ABI) < 0.9
• Fontaine class 2 (Intermittent claudication)

• Neoplasia and inflammation in the area intended for treatment
• Coagulation diseases, thrombocytopenia with platelet count less than 100,000/microliterand/or anticoagulant therapy
• Pregnancy
• Unstable coronary artery disease
• Aneurysm or acute or chronic thrombus

Warnings and Precautions
There is no treatment limitation in patients treated with anti-aggregants such as Aspirin or Clopidogrel. However, the treating physician should take into consideration the bleeding tendency resulting of their uptake and might consider changing anti aggregants regimen prior to shock wave treatment.

Treatment protocol
1. A total of 6 treatment sessions will be applied during two consecutive weeks 3 times per week OR during three consecutive weeks, 2 treatment sessions per week.

2. In each treatment session, the patient will receive a total of 2700. If the occluded artery/arteries are recognized apply SW according to A; In patients in which the occluded artery/arteries are not recognized, apply SW homogenously to the ischemic calf area as described under clause B.

A. SW are applied to the area of the occluded artery/arteries:
(a) 300 shocks per spot (spot is an area with a diameter of 3cm), and 9 spots will be treated in a single session.
(b) The SW should be applied to the occluded artery/arteries area and along the course of these arteries.
(c) Total number of shockwave pulses for the whole treatment course –16,200.

B. SW is applied to the entire ischemic calf area:
(a) 150shocks per spot (spot is an area with a diameter of 3cm) and 18spotson the ischemic calf muscle will be treated in a single SW session
(b) Total number of shockwave pulses for the whole treatment course –16,200.

Treatment procedure
1. Patient positioned on the treatment table with the treatment area exposed. The area is generously spread with ultrasound gel.
2. During the treatment, shock wave applicator directed perpendicular to the treatment area with membrane in close contact with the skin.

Recommended pre- and post-treatment evaluation
It is recommended to evaluate the patient 3 months after the treatment with the following measures:
• Walking Impairment Questionnaire (WIQ)
• Fontaine Class of Peripheral Artery Disease
• Total Ankle-Brachial Index
• Maximum Walking Distance per treadmill exercise test.
• Pain-free walking distance (meters)
• Low limb blood pressure measurements
• Lower extremity angiography