Medtronic and FDA Face
Scrutiny on Safety Issues
October 17, 2007; Page B7
Dallas Morning News (
www.dallasnews.com)
Medtronic Inc.'s decision to stop selling potentially defective defibrillator
leads has prompted scrutiny of the devices and of how safety concerns about
them were handled by the company and the
Food
and Drug Administration.
Plaintiffs attorneys, a consumer group and
Iowa Sen.
Chuck Grassley are
examining the history of the
Sprint
Fidelis leads, which are electrical wires
that connect the hearts of patients to the defibrillators implanted in their
chests.
On Monday,
Minneapolis-based Medtronic disclosed that the Sprint Fidelis
wires have fractured in about 2.3% of the 268,000 models made, 235,000 of
which are still implanted in people. The company said the fractures may have
contributed to five deaths.
In early signs of the pressure likely to come for Medtronic and the FDA,
Mr. Grassley, a
Republican, last night sent letters to the company and the
agency asking for more information about the leads. Separately, consumer
group
Public Citizen argued in a letter that the company and agency should
have taken action sooner.
In addition, a group of plaintiffs attorneys, which has been a leader in
major heart-device lawsuits, filed suits against Medtronic related to the
Sprint Fidelis leads in federal court in Minneapolis and
Puerto
Rico, according
to Hunter Shkolnik, one of the lawyers.
The investigations are likely to again focus attention on the FDA's oversight
of medical devices, which are regulated under different standards than drugs.
For instance, the Sprint Fidelis leads, which went on the
U.S. market in
2004, weren't required to be tested in humans before they won FDA approval.
Previous versions were tested in humans, but the Sprint Fidelis models weren't
different enough from those earlier iterations to require human trials, the
FDA said.
Medtronic says it did start clinical trials for
two of the four Sprint Fidelis models before they were sold in the U.S.,
one in 80 patients and the other in 81 patients, but didn't include these
in its FDA application because they weren't required. The devices "passed the objectives of the study," which
wasn't designed to assess long-term fracture risk, a Medtronic spokesman
said.
Medtronic said in a letter to physicians this
March that its investigation suggested that "variables within the implant procedure may contribute
significantly to these fractures," an issue that potentially would arise
only when doctors actually placed the devices into humans.
Before approving the Sprint Fidelis models, the
FDA reviewed results from animal tests and extensive engineering "bench" studies, including
400 million repetitions of a bending motion designed to answer questions
about the devices' strength, said Megan Moynahan, chief of the FDA branch
that oversees defibrillator leads. Because the fracturing issue is "extraordinarily
rare," a human clinical trial was unlikely to find it, she said.
Ms. Moynahan said the agency began watching the
devices more closely in February. But "the lead didn't appear to be performing any differently" than
other similar products, she said, and there wasn't a clear signal of a problem. "We've
had this closely on our radar and our concern has been building," she
said."
Medtronic said in a statement that when it "had
the appropriate information to make a decision regarding the Sprint Fidelis
defibrillation lead, we did so ... with patient safety and well being as
our primary concern."
Write to Anna Wilde Mathews at
anna.mathews@wsj.com4 and Thomas M. Burton
at
tom.burton@wsj.com5.
By ANNA WILDE MATHEWS and THOMAS M. BURTON