HEALTH CARE
FDA Approves Device: Luther Medical Products Inc., based in Tustin, has the inside track on a $50-million market, thanks to a decision by the U.S. Food and Drug Administration.
The maker of medical catheters said on Tuesday that it has received FDA approval to begin selling its silicone catheter, Sil-Cath, a device that was invented several years ago by Ron Luther, the company’s founder and chairman.
The catheter is unique because it has a “peel-away” needle system. The needle splits to allow catheters to be inserted into patients. Once the catheter is in the body, the needle is peeled off and discarded.
The FDA approval comes two years after Luther Medical won a patent battle over the peel-away needle, which was designed because of fears over needle contamination in the wake of the AIDS epidemic.
Tuesday’s announcement that the company can begin selling the product immediately means that Luther Medical is the nation’s sole supplier of the product.
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