Thursday, December 07, 2006

FDA Panel Assesses Drug-Eluting Stents and Clotting

Questions about whether the risks of clotting, heart attacks and death are higher for patients with drug-eluting stents compared bare stents are the subject of a two-day panel by the FDA. The questions center on whether and how long patients with the drug-eluting stents should stay on anti-clotting drugs such as Plavix. In a worst case scenario, the elevated risks, which the FDA does believe exists, could ultimately sabotage a $5 billion market for the devices.

Principal players (with a bevy of newcomers waiting in the wings) Boston Scientific and Johnson & Johnson have different spins on the risk. Boston Scientific "acknowledges a slight increase in clotting associated with its drug-coated stent, the Taxus," but the company asserts that there is no corresponding increased risk of heart attack or death. Johnson & Johnson argues that the risk of clotting, heart attack or death is equivalent for drug-eluting and bare stents.

The question of increased risk of clotting will certainly influence approvals of pending drug-eluting stents from Medtronic, Abbott and others.

Detailed coverage of the drug-eluting stent market is provided in the October 2006 issue of MedMarkets (subscribers).

Tags: medtech, stents

Wednesday, December 06, 2006

Orthopedic Biomaterials Global Market

Orthopaedic devices are a major contributor to the global medical device market, accounting for almost $26 billion in 2006, and with a growth rate that reflects growth in the medical sector overall. The table below gives a market growth projection for the five years 2007-2011.


Worldwide Sales
($millions)

Growth
(%)

2006

25,764

--

2007

27,122

5.3%

2008

28,562

5.3%

2009

30,989

8.5%

2010

31,708

2.3%

2011

33,425

5.4%

CAGR
'06-'11

5.3%




Orthopaedic Biomaterials
The current valuation of the orthopaedic biomaterials segment is around $5 billion, representing over 17% of the orthopaedic total. It is also estimated that this market segment will grow at 10-12% a year, that is more than double the rate for the overall orthopaedics market. At this rate the biomaterials segment will achieve a value of $9.5 billion by 2011 and will represent 28% of all orthopaedic product sales.


The global market for orthopedic biomaterials is analyzed in a new report from MedMarket Diligence (www.mediligence.com).

Tags: medtech, orthopedic