St. Jude Medical Inc.
) recently revealed a new data analysis from its CHAMPION trial
which was conducted to evaluate the safety and efficacy of the
company's CardioMEMS Heart Failure (HF) System for patients with
New York Heart Association (NYHA) Class III HF. The new data
analyzed the outcomes of a subgroup of patients with renal
dysfunction (kidney failure).
Patients with heart failure also often suffer from chronic kidney
disease. Medical therapies to avoid hospitalization may sometimes
adversely affect renal function. Notably, the latest results from
the CHAMPION trial demonstrated that monitoring the control group's
pulmonary artery pressure with St. Jude Medical's CardioMEMS HF
System can reduce hospitalizations without compromising kidney
function in patients with renal failure.
The CardioMEMS HF System is a first-of-its-kind heart failure
monitoring device that has proved to significantly reduce heart
failure-related hospitalizations. A miniature wireless sensor that
is threaded into the pulmonary artery is used to track the level of
pressure borne by heart-failure patients.
The implantable device is designed to detect early signals of
rising pressure and worsening heart failure. Patients can
wirelessly transmit the readings to their doctor who can
proactively manage medications and other treatment options to avoid
a crisis that could result in hospitalization.
St. Jude Medical acquired privately held CardioMEMS, Inc. - the
developer of the CardioMEMS HF System - in June this year,
following the U.S. Food and Drug Administration's (FDA) approval of
the device in May.
The FDA approval of the CardioMEMS HF System was gained on the
basis of earlier results from the CHAMPION trial, which found that
monitoring the amount of pulmonary artery pressure via the
implanted device lowered hospitalization rates by 28% at six months
and 37% after an average of 15 months.
However, the agency requires the company to conduct a thorough
post-approval study to ensure no unexpected risks or performance
problems emerge when the device is used outside a clinical trial.
Last month, the Center for Medicare and Medicaid Services (CMS)
approved a New Technology Add-on Payment (NTAP) for the CardioMEMS
HF System. Under the NTAP program, which recognizes new
technologies that provide substantial clinical benefits, Medicare
patients will have timely access to CardioMEMS technology to
proactively manage heart failure, improve patient outcomes and
reduce hospital admissions.
With the closure of the CardioMEMS acquisition during the second
quarter, St. Jude Medical expects accelerated growth in its
cardiovascular segment. In its recent second-quarter earnings
release, St. Jude Medical stated that it expects the monitoring
system to generate $15-$20 million in sales in 2014.
St. Jude Medical now plans to commence the system's launch in the
U.S. and pioneer an entirely new market with this innovative
technology. The company is also simultaneously beginning the
process of establishing appropriate reimbursement for its
CardioMEMS technology in key international markets.
During the remainder of this year, St. Jude Medical plans to
initiate the FDA mandated post-approval clinical trial, establish
key reference centers in the U.S., recognize any challenges that
customers might face while incorporating the CardioMEMS technology
into their existing heart failure program workflows, and refine the
training and education process provided to both St. Jude Medical
employees as well as customers.
Currently, St. Jude Medical carries a Zacks Rank #3 (Hold).
Better-ranked stocks in the medical products industry include ICU
), Abaxis, Inc. (
) and Eagle Pharmaceuticals (
). ICU Medical sports a Zacks Rank #1 (Strong Buy), while both
Abaxis and Eagle Pharmaceuticals carry a Zacks Rank #2 (Buy).
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