ó Joe Jones has been hospitalized half a dozen times
for heart failure.
recently, he was discharged from the hospital on his
birthday, Dec. 30. But Jones, 56, knew from experience
that it wouldnít be long before he felt that familiar
shortness of breath again and would have to go back to
the emergency room.
decided not to wait for another emergency. Instead, he
went in for a 30-minute procedure last week to get a new
diagnostic device called CardioMEMS permanently threaded
into the pulmonary artery near his heart, becoming the
first patient in the Twin Cities to get the device
following a lengthy approval process from the U.S. Food
and Drug Administration.
tiny batteryless gadget, made by St. Jude Medical, can
detect signs of impending heart failure events before
they devolve into stressful and costly emergencies.
might keep me out of the hospital," Jones said
hopefully from his bed.
was held up for years at the FDA, as experts debated the
safety of implanting the device and whether the
underlying clinical trial was biased. The rate of
complications from implantation was eventually judged to
be minimal, and the FDA cleared the device last May.
St. Jude is hoping that thousands of patients ó many
thousands, in fact ó will follow in Jonesí lead.
hope and belief is that this will become standard of
care," said Dr. Mark Carlson, chief medical officer
for St. Jude. "We believe that this device and the
therapeutic approach associated with this device will
transform the care of heart failure."
least 5.5 million Americans have heart failure, and
500,000 new cases are diagnosed each year. Heart failure
is a common condition that occurs when the heart doesnít
pump as much blood as it should, creating shortness of
breath and fatigue. Although most patients are
hospitalized after they feel physical symptoms, clinical
studies found that CardioMEMS can accurately detect
small changes in blood pressure between the heart and
lungs that predict an impending crisis.
adjusting prescription-drug intake and diet based on
same-day readings, patients with CardioMEMS were 37
percent less likely to be hospitalized than those who
had a device implanted but didnít have active
monitoring of their data, a company-sponsored study
found. The reduction was much steeper when looking only
at patients over age 65, which is relevant to hospitals
facing steep penalties when too many Medicare patients
are readmitted for heart failure symptoms.
numbers catch the attention of hospital administrators,
as well they should," Carlson said.
Jude is projecting $70 million in revenue this year from
the device, and Wells Fargo analyst Dr. David Y. Brill
said sales could hit $192 million by 2017. The company
is not commenting on reports that each device costs
roughly $20,000, though it celebrated the news last
August that Medicare had bumped up funding to pay for
it. Jones said his private insurance plan covered his
analyst Mike Matson at Needham & Co. summarized St.
Judeís sales prospects for 2015, he called CardioMEMS
"clearly the biggest potential growth driver"
for the company. He estimated sales this year would hit
$90 million, based on the fact that St. Jude had 90
sales contracts already from a pool of 325 heart failure
clinics around the country targeted for sales.
is a first-of-its-kind device on the market, according
to the FDA, although Medtronic has a similarly small
implantable diagnostic device called the Reveal Linq
that measures cardiac rhythm in patients with
unexplained fainting. Analysts see Linq as a near-term
revenue-driver at Medtronic as well.
St. Jude device was developed by an Atlanta-based
company called CardioMEMS, which St. Jude acquired last
year for $375 million just after the FDA approved the
device. St. Jude had already invested $60 million for
the exclusive right to buy the company following FDA
device itself is just slightly larger than a standard
USB port on a computer, and it includes two
nickel-titanium wires that protrude like moth wings to
secure the device in a patientís pulmonary artery
until it gets covered with tissue that permanently
embeds it in the body. It has no battery. Rather, the
energy to trigger a reading from the device comes from a
"wand" embedded in a special mat that a
CardioMEMS patient lies on at home. The readings are
sent to a company website, where doctors can view it in
wand has the radio-frequency energy in it, and that
excites the sensor to generate the wave form" that
contains the blood-pressure reading, said Dr. Steven
Goldsmith, of the hospital where Jonesí procedure was
performed. "So, no moving parts, nothing to wear
Anderson said thatís good news to him.
54, has been hospitalized for heart failure at least
five times, including twice in January and once this
month. His heart pumps at about 30 percent capacity
today, after a major heart attack last July.
I call 911, they come to me real quick," he quipped
just before he became one of three patients to get
CardioMEMS last week, along with Jones. "If it will
keep me out of the hospital, Iím all for it."