Mayo Clinic Gets $48 Million For Major Atrial Fibrillation Study
June 12 2009 - 2:17PM
Dow Jones News
The Mayo Clinic has secured $48 million in grants from St. Jude
Medical Inc. (STJ), a Johnson & Johnson (JNJ) subsidiary and a
U.S. research institute for a major trial that could eventually
spur more use of devices to treat a common heart-rhythm
problem.
Atrial fibrillation, which involves disorderly heart beating
that can heighten the risk of strokes, already represents a
fast-expanding market for catheters that typically use heat to
destroy tissue linked to the disorder. The market's growth profile,
at more than 15% a year according to Morgan Stanley, has attracted
medical-device companies such as Medtronic Inc. (MDT) seeking to
offset slower growth in more mature markets.
Still, there hasn't been a large-scale study yet that clearly
establishes the merits of device treatment in comparison with
drugs, which remain the typical first-line treatment for atrial
fibrillation.
Enter the "Cabana" trial, which will include 140 centers
tracking 3,000 patients who will be split between treatment with
so-called ablation catheters or drugs to control their heart rhythm
for two to five years.
The study's main goal is to test whether using catheters to
treat the disorder is better than drug therapy - which has been
shown to have some drawbacks - in reducing mortality. The study
will also track several other measures of safety and
effectiveness.
Morgan Stanley analysts recently called Cabana a "landmark
study" that could prove very meaningful for the atrial fibrillation
market. Establishing devices as a first-line treatment for the
disorder "has the potential to more than double the current annual
ablation volume," they said.
Researchers are keeping the study "wide open" while they seek to
answer tough questions, and either treatment method could look
better, said Douglas Packer, a cardiologist at the Mayo Clinic and
the Cabana study's principal investigator.
But he does see this as a landmark study that will help
establish how patients with the heart disorder - which is the most
common arrhythmia - are treated.
"I think that regardless of the outcome, the number of patients
and the strength of the trial should have substantial impact of
therapy," Packer said.
The catch is that it will take six years until results from
Cabana, which will start enrolling patients in August, will be
released. Morgan Stanley suggested interim results could come as
early as 2011, but Packer said there is no plan to release data
along the way.
Results from a small pilot study on 60 patients, used to help
set parameters for the big study, could be released as early as
August.
St. Jude is paying $20 million to fund Cabana while the National
Heart, Lung, and Blood Institute is paying $18 million and
J&J's Biosense Webster subsidiary is spending $10 million.
Both St. Jude and Biosense Webster have established
catheter-ablation businesses. Biosense Webster became in February
the first company to win Food and Drug Administration approval to
specifically market ablation catheters to treat a certain type of
atrial fibrillation. Before then treatment was done "off label"
with catheters approved for other purposes.
Medtronic recently established itself as a big potential player
by buying two small companies with devices under review, including
one with technology that freezes tissue rather than burning it to
disengage faulty signals.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com