FDA Approvals: SmartVest Trimline, C2a-Taper, Novus 3000

Yael Waknine

February 17, 2006

Feb. 17, 2006 — The US Food and Drug Administration (FDA) has approved a respiratory vest system for use in patients requiring percussive therapy to enhance mucus transport; a ceramic-on-ceramic hip prosthesis for arthroplastic use in patient with noninflammatory degenerative joint disease; and a photocoagulation device for use in the treatment of ocular pathologies.


Powered Percussor System (SmartVest Trimline) Promotes Airway Clearance

On December 1, 2005, the FDA approved a powered airway clearance system (SmartVest Trimline, made by Electromed, Inc) for use in patients requiring percussive therapy to enhance mucus transport.

Applications include cystic fibrosis, bronchiectasis, obstructive pulmonary conditions and other diseases such as multiple sclerosis and muscular dystrophy.

The system consists of a compact, portable generator that produces oscillating pressurized air pulses that are delivered through a hose to an inflatable vest, causing it to rapidly inflate and deflate against the patient's chest wall. Delivery of high-frequency chest wall oscillation serves to mobilize bronchial secretions, thereby improving airway clearance and improving bronchial drainage.

The system can be programmed with up to 3 individual patient therapy prescriptions and fits into a 2-wheeled case sized to fit under airplane seats or in overhead bins for convenience.

The vest is available in a wide range of sizes to fit patients aged as young as 18 months to large adults, and is made of washable fabric rather than plastic to reduce perspiration and itching.


Hip Prosthesis (C2a-Taper) for Use in Patients With Degenerative Joint Disease

On December 16, 2005, the FDA approved a prosthetic device (C2a-Taper acetabular system, made by Biomet, Inc) for use in primary total hip arthroplasty in skeletally mature patients with noninflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and posttraumatic arthritis.

The acetabular system features ceramic-on-ceramic articulation and a coating of titanium alloy particles to achieve solid fixation.

The approval was granted in part due to a licensing agreement between Biomet and CeramTec, which owns the rights to the Transcend ceramic hip system that was combined with Biomet's acetabular shells and femoral stem components in the new device.


Photocoagulation Device (Novus 3000) for Use in Treating Ocular Pathologies

On November 15, 2005, the FDA approved a 532-nm diode-pumped solid-state (DPSS) coagulator (Novus 3000, made by Lumenis Limited) for use in the treatment of ocular pathology.

The device is indicated for use in photocoagulation of anterior and posterior segments to treat proliferative and nonproliferative diabetic retinopathy, choroidal neovascularization, branch retinal occlusion, age-related macular degeneration, retinal tears and detachments, and retinopathy of prematurity. The device can also be used for iridotomy, iridectomy, and trabeculoplasty in the treatment of glaucoma.

The device features a color touch screen and liquid crystal display remote control that enable instantaneous adjustments to treatment parameters. In addition, multiple memory locations allow ophthalmologists to save and recall preferred treatment parameters. The unit has built-in storage for a laser indirect ophthalmoscope (LIO), remote control, foot switch, and other accessories.

The system's design also expands treatment options by incorporating 2 illumination sources that work independently with compatible LIOs and endo-ocular probes. A dual-fiber port allows attachment of 2 delivery devices at any time for immediate use during procedures.

Reviewed by Gary D. Vogin, MD

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