Article preview from Medtech Insight - August, 2010
Brief summaries of recent medtech market and industry developments. This month we cover trial results for PFO closure devices, the launch of Edwards Lifesciences' transcatheter valve, Accumetrics' push for platelet testing, J&J;'s acquisition of Micrus, the slowdown in the hip and knee market, and the new federal rule on covering preventive screening.
Market & Industry Briefs: Cardiovascular, Neurovascular, Orthopedics/Spine, Regulatory, Around the Industry
Article preview from Medtech Insight - August, 2010
Cardiovascular
CLOSURE I PFO Trial Misses End Point, but Findings Could Have Silver Lining
Randomized clinical trials investigating percutaneous patent foramen ovale (PFO) closure in the US have continued to progress in 2010. These trials are striving to gather data that would support Premarket Application approval by the US Food & Drug Administration (FDA), which would allow for the first FDA-approved indication specifically for the closure of PFO. ( See Exhibit 1.)
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In April, NMT Medical Inc. achieved an important milestone with the lock down and initiation of data analysis for CLOSURE I, a randomized trial comparing PFO closure using the STARFlex device versus current best medical therapy in patients with a PFO and a history of cryptogenic stroke or transient ischemic attack (TIA). However, in June, NMT announced that the preliminary data analysis of CLOSURE I did not meet the primary end point of a statistically significant benefit for PFO closure over current best medical therapy for prevention of recurrent strokes or TIAs. Full release of CLOSURE I data is slated to take place during the American Heart Association annual meeting in November 2010.
NMT did report a small, but not statistically significant, benefit to closure with STARFlex over current best medical therapy, and the safety profile for the device was positive, with a low rate of complications, the firm said. The PFO closure rate in the study was 86.5%, which NMT said is consistent with previous reports for the STARFlex implant and in line with closure rates of other percutaneous PFO closure devices.
NMT's president and CEO, Frank Martin, expressed disappointment with the results and said the firm is discussing "possible next steps" with the FDA for the stroke/TIA indication. The company is also analyzing the full data set from the trial to better understand the clinical and regulatory options, Martin said in a statement.
Following the announcement, analysts expressed concern that the CLOSURE I results would prevent the FDA from approving the device for PFO closure, and Wall Street reacted negatively to the news, punishing NMT's stock with a nearly 75% price drop. However, others in the PFO industry preferred to put a more positive spin on the news. John Barr, president and CEO of AGA Medical Holdings Inc., one of NMT's largest competitors, called the trial results "encouraging," as they "suggest that PFO closure may be at least as good as medical therapy and may be safe." Barr noted that warfarin ( Coumadin), one of the options for medical therapy, has a difficult dosing regimen and the potential for severe complications, which encourages patients to avoid Coumadin therapy if possible.
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