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FDA Approvals: Spy, Reflection, Kodak Mammography CAD Engine

Jan. 31, 2005 — The U.S. Food and Drug Administration (FDA) has approved an imaging system to validate graft patency during coronary artery bypass graft surgery, a ceramic acetabular system for use in total hip arthroplasty, and a software system that identifies suspect areas on screening and diagnostic mammograms.

Imaging System (Spy) Validates Graft Patency During CABG Surgery

On Jan. 24, the FDA approved an intraoperative imaging system (Spy, made by Novadaq Technologies) for use in confirming the proper placement of grafts and assessing their functionality during both on- and off-pump coronary artery bypass graft (CABG) surgery.

The system uses a fluorescent dye injection (indocyanine green) to visualize blockages or restrictions just prior to surgery and validate graft patency during surgery. The hardware includes an imaging head with an automatic range detector for accurate focusing on a retractable arm. The laser light source is activated using a computer system, and the resulting digital image is displayed on the high-resolution monitor in real time and documented on DVD for further review and/or printing.

According to a company news release, use of the system in clinical studies demonstrated that as many as 5% of all bypass grafts were not functioning properly after placement. Identification and revision of these grafts during surgery may avert later complications.

The system was approved for use in Canada and the European Union in October 2001.

Ceramic Acetabular System (Reflection) for Total Hip Arthroplasty

On Dec. 17, the FDA approved a ceramic acetabular system (Reflection, made by Ceramtec for Smith & Nephew, Inc.) for use in patients requiring primary total hip arthroplasty due to noninflammatory arthritis such as osteoarthritis, avascular necrosis, or traumatic arthritis.

The ceramic-on-ceramic hip prosthesis system includes an acetabular shell with a porous coating and an alumina ceramic acetabular shell liner/inset and femoral head.

Use of the implant is contraindicated in patients with insufficient quantity or quality of bone support, metabolic bone disease, osteoporosis, active joint infections or chronic systemic infection, and neurologic or muscular conditions that would place extreme load or instability upon the hip joint. It is also contraindicated in obese patients (three times normal body weight) and in patients with immature skeletons.

The system was approved for use in the European Union, Australia, and Canada in October 1998, February 1999, and April 2002, respectively.

The FDA warns that improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions and early failure/fracture. Surgeons should be familiar with certain insertion techniques that may differ from those used for conventional hip systems and are designed to avoid potential implant failures. The implant has not been withdrawn from any country due to safety and effectiveness reasons.

Software System (Kodak Mammography CAD Engine) Minimizes Observational Mammogram Oversights

On Nov. 23, the FDA approved a software system (Kodak Mammography Computer-Aided Detection [CAD] engine, made by Eastman Kodak Co.) to identify and mark regions of interest on routine screening and diagnostic mammograms, thereby minimizing observational oversights by radiologists.

The approval was based on the results of clinical trials showing that 39.4% of missed breast cancers could have been detected 14.8 months earlier using the device.

The software uses algorithms to identify suspicious areas on patients' digitized mammograms for review by the radiologist prior to making a final diagnosis. The device is intended for use as a diagnostic aid only. The FDA notes that a radiologist's decision concerning an originally observed suspicious area should not be changed due lack of recognition by the CAD engine.

Reviewed by Gary D. Vogin, MD