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New Device Approval

Orthospec^TM Extracorporeal Shock Wave Therapy - P040026

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: OrthospecTM Extracorporeal Shock Wave Therapy
Applicant: MEDISPEC, LTD.
Address: 12850 Middlebrook Road, Suite 1, Germantown, Maryland 20874
Approval Date: April 1, 2005
Approval Letter: http://www.fda.gov/cdrh/pdf4/p040026a.pdf

What is it?
The OrthospecTM Extracorporeal Shock Wave Therapy device is a non-invasive, alternative to surgery that uses strong sound waves (extracorporeal shock wave energy) to relieve heel pain (proximal plantar fasciitis). Proximal plantar faciitis is an inflammation of the plantar fascia, the band of connective tissue that stretches from the base of the toes, across the arch of the foot, and inserts into the heel bone.

How does it work?
The Orthospec™ generates pulses of high pressure sound that travel through the skin (extracorporeal shock wave therapy) to initiate tissue repair.
The Orthospec™ uses an electro-hydraulic, or “spark gap” method of creating the shock wave. With this technique, an electrode (spark plug) ignites an electrical charge within a water-contained, stainless steel, semi-ellipsoid chamber and contact membrane, evaporating a small portion of the water and creating a shock wave reflecting outward off the ellipsoid. The shock wave is generated within the reflector chamber and transmitted through the skin surface of the patient to the treatment site. Coupling solution is used on both the contact membrane and the patient's skin during treatments to enhance conductivity.

When is it used?
The OrthospecTM is indicated for the treatment of proximal plantar fasciitis with or without heel spur in patients:

• who are 18 years of age or older
• who have had proximal plantar fasciitis for 6 months or more
• for whom conservative therapies, such as rest or exercise, have failed to relieve heel pain

What will it accomplish?
The Orthospec™ investigation provides sufficient valid scientific data that demonstrates the Orthospec™ Extracorporeal Shock Wave Therapy modality to be a safe and effective tool in treating pain caused by Proximal Plantar Fasciitis. The double-blind study demonstrates clinical success to be unbiased and encouraging. After the exhaustion of conservative means, surgical plantar fasciotomy was the practitioners' choice treatment for the reduction of heel pain. However, Extracorporeal Shock Wave Therapy with the Orthospec™ device as the data show, offers the patient a more safe and viable option prior to surgical intervention.

Potential adverse events when using the Orthospec™ device include:

• Petechia (small purplish spots on the skin caused by bleeding just beneath the skin surface)
• Bruising
• Mild local swelling
• Superficial hematoma (localized swelling filled with blood resulting from a broken blood vessel)
• Neurosensory conditions (Hypesthesia or Parasthesia)

When should it not be used?
The Orthospec™ should not be used:

• Over or near bone growth centers until bone growth is complete
• When a malignancy is know to be present in or near the treatment area
• When the treatment site has open wounds, skin rashes, swollen, inflamed, or infected areas
• Over ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis may result
• In a patient who has a coagulation disorder or is taking anticoagulant medications, either for acute or chronic anticoagulant therapy
• In a patient who has an infection at the treatment site to avoid the risk of spreading infection
• In a patient who has a history of latex allergy or allergy to coupling solution

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf4/p040026.html

Other

Plantar faciitis:
http://www.mayoclinic.com/invoke.cfm?objectid=C5D42AB4-5AC4-4CA8-BA3BC6318C19E3CF&dsection=1

http://orthoinfo.aaos.org/fact/thr_report.cfm?Thread_ID=144&topcategory=Foot

Heel Pain: http://www.apma.org/s_apma/doc.asp?CID=371&DID=9408

Updated September 15, 2005

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