The Cypher drug-eluting stent.
Drug-eluting stents are designed to prevent restenosis and act as a scaffold to hold open narrowed arteries. A traditional bare metal stent coated with a time-release drug component, the drug-eluting stent is often used as a prime example of a combination product. Approved by FDA in 2003, the Cypher Sirolimus-eluting stent—the first such device—was manufactured by Cordis Corp. (Miami Lakes, FL; www.cordis.com). Fanfare marked the release of the revolutionary combination product. Criticism soon followed, however, with the release of data suggesting that patients with drug-eluting stents are at slightly more risk of stent thrombosis. A special panel convened by FDA in December 2006 concluded that the benefits of proper use of the drug-device products compared with traditional metal stents outweighed concerns about thrombosis.
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Inhalers have been used for years to treat patients suffering from asthma. However, FDA’s approval of the first inhaled insulin combination product in 2006 demonstrated that other conditions could benefit from this drug-delivery method. Manufactured by Pfizer Inc. (New York City; www.pfizer.com), Exubera is a powdered form of insulin administered by a specially designed inhaler for the treatment of type 1 and type 2 diabetes. The product offers an alternative to insulin injections for the millions of people living with the disease. This breakthrough combination product has inspired companies to explore other therapies that could be inhaled. In 2006, Vectura Group plc (Chippenham, Wiltshire, UK; www.vectura.com) announced the successful outcome of a Phase II proof-of-concept clinical study for an inhaled product for the treatment of induced “off” periods in patients with Parkinson’s disease.
Beyond Combination Products
The term convergent technologies is often viewed as synonymous with combination products. However, there are numerous examples of the marriage of two technologies to create a new platform outside of an innovative drug-device product. This is especially true in advancements pertaining to electronics applications. Transceivers embedded in implantable devices enable communication and data transfer to an outside source.
Chips can be embedded in flex circuits, PCBs, and even human bones.