St. Jude Medical now intends to exercise its exclusive option to
purchase CardioMEMS and begin a strategic U.S. launch
ST. PAUL, Minn. & ATLANTA--(BUSINESS WIRE)--
Jude Medical, Inc. (NYSE:STJ), a global medical device company, and
CardioMEMS, today announced U.S. Food and Drug Administration (FDA)
approval of the CardioMEMS™ HF System. The CardioMEMS HF System is the
first and only FDA-approved heart failure (HF) monitoring device that
has been proven to significantly reduce HF hospital admissions when used
by physicians to manage heart failure.
The CardioMEMS HF System uses a miniaturized, wireless monitoring sensor that is implanted in the pulmonary artery. (Photo: Business Wire)
The CardioMEMS HF System uses a miniaturized, wireless monitoring sensor
that is implanted in the pulmonary artery (PA) during a minimally
invasive procedure to directly measure PA pressure. Directly measuring
PA pressure via a procedure called a right-heart catheterization is a
standard-of-care practice for managing worsening HF in patients who have
been hospitalized. The CardioMEMS HF System allows patients to transmit
the same information from their homes to their health care providers
allowing for personalized and proactive management to reduce the
likelihood of hospitalization.
Heart failure occurs when the heart is unable to pump enough blood to
meet the body’s demands and blood pressure within the heart is elevated.
Significant HF progression over a period of days is known as acute
decompensation and leads to hospitalization. Increased PA pressures
often precede indirect measures of worsening HF such as weight and blood
pressure changes. The CardioMEMS HF System allows clinicians to
stabilize PA pressures by proactively managing medications and other
treatment options while also providing an early indication of worsening
“I believe this strategy has the potential over time to change heart
failure. Not just to lighten the burdens every day or to decrease the
number of hospitalizations, but to decrease the grim progression of the
disease,” said Dr. Lynne Warner Stevenson, director of the Heart Failure
Program at Brigham and Women’s Hospital in Boston.
Eric S. Fain, M.D., group president of St. Jude Medical, congratulates
CardioMEMS on this historic accomplishment in the treatment of heart
failure, and said, “The CardioMEMS HF System will not only improve the
lives of patients but will also reduce the economic burden of this
epidemic disease and we are delighted to have CardioMEMS become a part
of St. Jude Medical.”
“We want to thank the patients and clinicians who worked with us to
prove the benefit of the CardioMEMS HF System. We also want to thank FDA
for making this technology available to heart failure patients in the
United States,” said Jay S. Yadav, M.D., founder and CEO of CardioMEMS.
“The CardioMEMS system creates a new paradigm for proactive management
of heart failure and will greatly benefit patients and their families.
We are excited to be working with St. Jude Medical, whose geographic
reach and focus in the area of heart failure will bring this much needed
treatment to patients around the world.”
The CardioMEMS HF System is supported by strong clinical evidence,
including data from the CHAMPION
(“CardioMEMS Heart Sensor Allows Monitoring
of Pressure to Improve Outcomes in NYHA
Class III Patients”) trial published in The
Lancet. The randomized, controlled CHAMPION clinical trial
proved the effectiveness of the CardioMEMS HF System in New York Heart
Association (NYHA) Functional Classification System class III HF
patients who had been hospitalized for HF in the previous 12 months. In
contrast to large-scale studies of tele-monitoring of weight, blood
pressure and transthoracic impedance such as Tele-HF,
the CHAMPION study showed that management based on PA pressures led to a
clinically significant reduction in HF admissions. Specifically, the
trial demonstrated a statistically and clinically significant 28 percent
reduction in the rate of HF hospitalizations at six months, and 37
percent reduction in HF hospitalizations during an average follow-up
duration of 15 months.
Commenting on the CHAMPION results, Fain said, “Unlike tele-monitoring
of weight and blood pressure, transthoracic impedance or intensified
clinic follow-up, the CardioMEMS HF System is the only FDA-approved
monitoring technology that has demonstrated the ability to significantly
reduce heart failure hospitalizations in a large-scale clinical trial.
This one-time implant, delivered using a catheter-based procedure, will
allow physicians to proactively manage pressures to an individually
tailored target rather than reacting to symptoms once a patient’s heart
failure has worsened.”
The Centers for Medicare & Medicaid Services (CMS) have implemented
initiatives to promote better outcomes, patient safety, and effective
care by requiring hospitals to collect data on various quality metrics,
most notably HF readmission rates. These data
are publicly available and the purpose is to increase hospitals’
accountability for quality outcomes in order to preserve reimbursement
for patient care. The CHAMPION trial demonstrates that the CardioMEMS HF
System provides both clinical and economic benefits for the health care
About the Acquisition
In September 2010, St. Jude Medical invested $60 million for 19 percent
ownership of CardioMEMS, with an exclusive option to purchase the
remaining 81 percent of the company for $375 million. St. Jude Medical
now intends to immediately exercise its exclusive option to acquire
CardioMEMS, and expects to complete the acquisition in the second
quarter of 2014.
BofA Merrill Lynch will act as financial advisor and Gibson, Dunn &
Crutcher LLP as legal counsel to St. Jude Medical. J.P. Morgan
Securities LLC will act as financial advisor to CardioMEMS and Cooley
LLP as legal counsel.
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About Heart Failure
More than 5
million Americans have heart failure (HF) with 670,000 new cases
diagnosed each year. Roughly 1.4 million patients in the U.S. have NYHA
Class III HF, and historically these patients account for nearly half of
all HF hospitalizations. According to the American Heart Association,
the estimated direct and indirect cost of HF in the U.S. for 2012 was $31
billion and that number is expected to more than double by 2030.
About CardioMEMS, Inc.
Headquartered in Atlanta, CardioMEMS is a medical device company that
has developed a proprietary wireless sensing and communication
technology for the human body. The company's technology platform is
designed to improve the management of severe chronic cardiovascular
diseases such as heart failure, aneurysms, and hypertension. The sensors
can be permanently implanted into the heart and blood vessels due to
their small size, durability and lack of wires and batteries. CardioMEMS
developed this technology based on the belief that frequent, on-demand,
real-time monitoring of vital information enables proactive patient
management leading to fewer hospitalizations, improved patient quality
of life, and more efficient and cost-effective health care.
CardioMEMS was founded by Jay Yadav, M.D., an interventional
cardiologist and entrepreneur. Lead investors in CardioMEMS include
Arcapita Ventures, which is led by John Huntz, Boston Millennia Partners
and Foundation Medical Partners. For more information, please visit www.cardiomems.com.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to
transforming the treatment of some of the world’s most expensive,
epidemic diseases. The company does this by developing cost-effective
medical technologies that save and improve lives of patients around the
world. Headquartered in St. Paul, Minn., St. Jude Medical has four major
clinical focus areas that include cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information,
please visit sjm.com
or follow us on Twitter @SJM_Media.
This news release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 that involve
risks and uncertainties. Such forward-looking statements include the
expectations, plans and prospects for the Company, including potential
clinical successes, anticipated regulatory approvals and future product
launches, and projected revenues, margins, earnings and market shares.
The statements made by the Company are based upon management’s current
expectations and are subject to certain risks and uncertainties that
could cause actual results to differ materially from those described in
the forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control and the
risk factors and other cautionary statements described in the Company’s
filings with the SEC, including those described in the Risk Factors and
Cautionary Statements sections of the Company’s Annual Report on Form
10-K for the fiscal year ended December 28, 2013 and Quarterly Report on
Form 10-Q for the fiscal quarter ended March 29, 2014. The Company does
not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.
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St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Source: St. Jude Medical, Inc.