We know that you may be too busy to keep track of the drug and technology market, so the professionals at Hayes, Inc. are tracking new developments for you! For example, the Food and Drug Administration (FDA) recently approved two novel technologies: an oral agent for patients with multiple sclerosis (MS) that may help their walking ability and the first percutaneous heart valve system. Hayes has been monitoring the development of these two first-of-a-kind technologies in Technology Prognosis, our horizon scanning service, and this is what we think about each new development:

Ampyra™ (Dalfampridine, Formerly Fampridine-SR; Acorda Therapeutics Inc.)
Ampyra was approved by the FDA on January 22, 2010, to improve walking in patients with any type of MS. Although Ampyra does not change the course of MS, it does represent an intriguing innovation in MS therapy because it is an oral agent that addresses an unmet treatment need. There is, however, uncertainty regarding the practical “real-world” relevance of pivotal trial results. The research suggested that a significantly higher proportion of patients treated with Ampyra versus placebo were able to walk faster, but the magnitude of improvement in the Ampyra group was so small that the actual walking speed in that group differed from that in the placebo group by less than 1 minute.

Hayes Viewpoint: Ampyra will likely be of great interest to MS patients and clinicians despite a paucity of evidence of practical “real-world” benefits.

Melody® Transcatheter Pulmonary Valve (Medtronic Inc.)
The Melody Transcatheter Pulmonary Valve was approved by the FDA on January 25, 2010, through its Humanitarian Device Exemption (HDE) program. The valve and delivery system are indicated to prolong the longevity of failing prosthetic pulmonary conduits in patients with right ventricular outflow tract (RVOT) dysfunction associated with congenital heart defects. Based on the best available evidence, implantation of the Melody valve may delay open heart surgery in selected patients with failing RVOT conduits. However, the long-term efficacy of this intervention to reduce the lifetime risk for exposure to multiple pulmonary valve surgeries is still being evaluated.

Hayes Viewpoint: The Melody valve is not expected to replace current care open heart surgery for initial placement of a pulmonary conduit, but may reduce the total number of open heart RVOT revision procedures required during a patient’s lifetime.

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