TCT Debates Cardiology's "Climate of Calamity"
The real story that came out of this year's Transcatheter Cardiovascular Therapeutics (TCT) meeting held in October in Washington, DC, is not the news per se regarding specific clinical trial results or new device technologies. Instead, it is the story behind the news. Interventional cardiology has been built on the back of evidence-based medicine. That methodology, however, has come under attack in the last year.
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As 2008 draws to a close, In Vivo takes stock of the major events affecting the medical device industry in 2008. Two stories continue to unfold; how the new Obama administration will control national health spending, and the financial crisis that hit the US and global economies. The latter is already taking its toll on medtech. Financial markets crashed, and so did public device companies. M&A dwindled as the year went on, with some notable--and surprising--exceptions, and the downturn is driving VCs to invest either extremely early or late. In other stories: the Department of Justice continued probing into physician conflict of interest matters, this time focusing on the influential Cardiovascular Research Foundation. Also from Washington, the 510(k) process is under review, and 2009 may see changes that make the process of demonstrating safety and effectiveness more costly for device companies. CMS instituted payment reforms affecting hospitals, although this may be good news for medtech companies offering products to help curb hospital-acquired infections and medical errors. The news was good in diabetes--for devices, not pharmaceuticals--with positive outcomes from a major trial on continuous glucose monitoring and two new markets opening up in diabetes for device manufacturers. The regulatory agency delivered some positive news to companies in cardiac rhythm management and neurostimulation too. And second generation drug-eluting stents found a market more receptive than it was a year ago.
The American Heart Association's scientific sessions in November 2007 presented new clinical data on drug-eluting stents, cardiac resynchronization, treatments for acute coronary syndrome, and better ways of diagnosing and treating myocardial infarction.
Looking back at 2007, the performance of the medical industry seems strong, from blockbuster M&A to a better-than-expected result of a years-long DOJ investigation into the orthopedics industry. Even Boston Scientific seemed finally to be turning the corner. Drug-eluting stents (DES) got a second chance as data presented from several trials showed better mortality than with bare-metal stents. Venture capitalists poured even more money into device start-ups, both young and old. The confidence shown by venture investors was, not surprisingly, reflected in an IPO market that appeared to continue its recent rebound. But there are also some concerns: company consolidation, increased safety concerns and litigation revolving around physician-manufacturer relationships are causing some to wonder how long the foundation on which the industry's strong showing of recent years can sustain.