Definitions

OssaTron

OssaTron

The OssaTron is a high energy shockwave system that provides a non-surgical alternative for patients diagnosed with chronic proximal plantar fasciopathy (severe heel pain), usually referred to as fasciitis. This non-invasive out-patient treatment represents a breakthrough for this condition. Using a unique process known as Orthotripsy, the OssaTron emits shockwaves, similar to those used to treat kidney stones, to increase blood flow and stimulate healing of the affected heel.

Device

The OssaTron is the first shockwave unit developed especially for orthopaedic applications. The OssaTron unites electrohydraulic shockwaves possessing a maximum penetration depth with a dynamic energy range and a large focal volume to create the "Gold Standard" in Extracorporeal Shock Wave Technology. The OssaTron covers a range of orthopaedic indications suitable for Shock Wave Technology. The OssaTron is the first and only Extracorporeal Shock Wave Technology (ESWT) system approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple orthopaedic conditions which have failed to respond to conservative treatment. The OssaTron is currently FDA approved to treat chronic plantar fasciitis (heel pain) and chronic lateral epicondylitis (tennis elbow) when these conditions have failed to respond to conservative treatments.

Procedure

Once anesthesia has been administered, high viscosity ultrasound gel is applied to the area experiencing pain (target tissue). The gel promotes shockwave conductance, enhancing treatment effectiveness. The Ossatron Application Technician then activates the shockwave via the shockwave release hand piece on the console.

Post-procedure

It is recommended after treatment that the patient restrict "stressful activity" such as jogging, heavy housework or yard work, and participating in sports for four weeks. Pain relief begins for patients at different times. For some patients it is immediate; for others it may take four weeks. The full effect of the OssaTron procedure may not be realized until the twelfth week following treatment. If relief has not been achieved at this point, a second OssaTron procedure may be recommended by the patient's physician.

Success rate

Orthotripsy with the OssaTron has been proven to be effective over 80% of the time with only one treatment. Some patients report immediate pain relief after treatment, although it can take up to four weeks for pain relief to begin.

Findings Questioned

A class action lawsuit settlement approved by a federal judge suggests that the manufacturer of the Ossatron made material misrepresentations and/or omitted to make material disclosures concerning the efficiency, testing and market acceptance of the OssaTron. According to the lawsuit the manufacturer failed to disclose to investors that some of its own tests failed to support its statements that the OssaTron was more effective, safer and less costly than alternative, nonsurgical treatments for heel pain and that serious questions existed among the medical community concerning the effectiveness of extracorporeal shock wave treatment (ESWT) for heel pain. See Thomas v. HealthTronics Surgical Services, et al. US Dstrict Court for the Northern District of Georgia, Civil Case No. 03-cv-2800.

References

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