August 2005 Issues

CMS Issues New Rules for Power-Operated Vehicles - Quick Pulse

Summary: CMS has issued an interim final rule on the prescribing, supplying, and reimbursement for power operated vehicles (scooters) and power wheelchairs. CMS appears to be trying to clamp down on overly aggressive durable medical equipment (DME) suppliers without denying legitimate claims.

Paris Course on Revascularization

Summary: European doctors were not very concerned about safety questions that have been raised about Boston Scientific’s Taxus stent, and doctors predicted overall market share would not change significantly during the rest of 2005, except perhaps in the U.K., where Johnson & Johnson’s Cypher stent appears to be gaining ground. ♦ European doctors are aware that Conor Medsystems is developing a drug-eluting stent and they have heard it is interesting, but few knew much about CoStar. ♦ Medtronic’s Endeavor stent is likely to gain more market share – and quicker – in Europe than previously thought. ♦ Stereotaxis’s Niobe navigation system is catching on, but slowly, in Europe. ♦ Several companies are investigating the use of PFO closure devices to treat migraine headaches. NMT Medical already has a trial fully enrolled in the U.K., but no one has an IDE for a U.S. trial yet.European doctors were not very concerned about safety questions that have been raised about Boston Scientific’s Taxus stent, and doctors predicted overall market share would not change significantly during the rest of 2005, except perhaps in the U.K., where Johnson & Johnson’s Cypher stent appears to be gaining ground. ♦ European doctors are aware that Conor Medsystems is developing a drug-eluting stent and they have heard it is interesting, but few knew much about CoStar. ♦ Medtronic’s Endeavor stent is likely to gain more market share – and quicker – in Europe than previously thought. ♦ Stereotaxis’s Niobe navigation system is catching on, but slowly, in Europe. ♦ Several companies are investigating the use of PFO closure devices to treat migraine headaches. NMT Medical already has a trial fully enrolled in the U.K., but no one has an IDE for a U.S. trial yet.

  When Can Discontinued Drugs be Re-launched? - Quick Pulse

Summary: When a drug is pulled from the U.S. market for safety reasons, that is usually the end of that drug. However, it is possible, in rare circumstances, for drugs to return to the market. Currently, companies are trying to bring back two drugs – Merck’s Cox-2 inhibitor Vioxx (rofecoxib) and Biogen Idec/Elan’s multiple sclerosis therapy Tysabri (natalizumab). To better understand the regulatory path for a relaunch of these and other withdrawn drugs, Dr. John Jenkins, Director of the FDA’s Office of New Drugs, was interviewed.