Melody® Transcatheter
Pulmonary
Valve |
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January 26, 2010 --
On Monday the FDA announced a breakthrough approval: the
first transcatheter heart valve, designed to be delivered
percutaneously
via catheter-based technology, much the way coronary stents
currently are placed -- valve replacement without open heart
surgery.
The recipient of this landmark approval was Medtronic's
Melody® Transcatheter
Pulmonary Valve and Ensemble Delivery System, a device which
received the European CE Mark four years ago. |
This approval is important for two reasons.
Breakthrough for Pediatric Heart Patients
First,
as stated in the FDA's press release, is that the Melody may be "especially
beneficial to pediatric patients with right-sided valvular heart
disease who may face several surgeries over their lifetimes." Congenital
heart defects, like leaky pulmonary valves, are the number one birth
defect worldwide. Since no valve permanently cures the condition,
and may need to be replaced over time, the possibility of a non-surgical
approach has significant benefit to young patients who may be facing
one, two or more valve replacements throughout their lifetime. The
FDA approved the Melody under the Humanitarian Device Exemption
(HDE) program, intended
to benefit patients in the treatment or diagnosis of diseases or
conditions affecting fewer than 4,000 people in the United States
per year. Medtronic is acting cautiously with this new technology,
noting that probably less than 1,000 patients will be treated
annually. The FDA is also requiring Medtronic to keep a database
of all recipients, and to conduct two post-approval studies of both
the long-term clinical results of patients, as well as evaluation
of the physician training program required for specialization in
this procedure.
Repairing Valves Via Catheter
Secondly, however, is the longer-term outlook
for transcatheter valves. While pulmonary valves represent a relatively
small segment of the population, not so with aortic and mitral
valve replacement. Such devices have been developed over the past
decade and are currently in limited use in Europe. Last year Medtronic
acquired CoreValve, one of the leaders in transcatheter aortic
valve replacement. Edward LifeSciences has been developing another
aortic valve -- and devices for the mitral valve as well. In fact,
the "hot" topic
at most of the interventional cardiology meetings these days is
percutaneous
valve
repair, so
the significance of yesterday's FDA approval is that of opening
of a whole new branch of interventional treatment that started over
thirty years ago on a kitchen table....
As for Medtronic, besides its transcatheter valves,
ENDEAVOR zotarolimus-eluting coronary stent (and next generation
RESOLUTE) and
aortic aneurysm
repair stent grafts, yesterday the company announced acquisition
of European manufacturer Invatec, along with its affiliated companies
Fogazzi and Krauth
Cardiovascular. This addition will provide Medtronic with a new
product line of peripheral catheters, balloon and stents, for treating
legs, below-the-knee and other peripheral vessels, as well as a
stronger presence and ready-made sales force in the European markets.
Balloons that Emit Drugs
But Invatec will also provide
Medtronic with a new technology: the drug-eluting balloon.
The IN.PACT™ Falcon paclitaxel-eluting PTCA balloon catheter
was shown at this year's EuroPCR meeting and in the words of
Prof. Eberhard Grube, Chief, Department of Cardiology/Angiology
at the Heart Center, Siegburg, Germany:
"Combining world-class
PTCA balloon catheter technology with local drug administration
is a fascinating new concept for the treatment of certain coronary
lesions such as In-Stent Restenosis (ISR), Small Vessel Disease
(SVD), Bifurcations and potentially other lesions where conventional
balloons, stents and even drug eluting stents may not be ideal."
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Eberhard
Grube, MD |
Various drug-eluting balloon (DEB) trials have
shown mixed results, but there are obvious advantages to opening
a blocked artery,
suppressing restenosis with a drug (paclitaxel in most DEB) and
leaving no hardware behind. The IN.PACT has a CE Mark, so results
from more robust trials should be forthcoming.
(Note: if readers are wondering why Medtronic's
transcatheter pulmonary valve is named "Melody" and the delivery
system is "Ensemble" -- that's because Professor Philipp Bonhoeffer,
Chief of Cardiology at Great Ormond Street
Hospital for Children in London, developed the valve along with
Medtronic and Dr. Bonhoeffer is an avid and very accomplished violinist.
Two years ago, this author attended an information session on the
Melody valve at the Veith
Symposium, and Dr. Bonhoeffer opened
the meeting, not with a PowerPoint presentation, but with a live
performance of the first two movements of Beethoven's "Spring Sonata",
Opus 24!)
Reported by Burt Cohen, January 26, 2010
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