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CardioMEMS sold to St. Jude Medical: Boston Millennia Partners announced that St. Jude Medical (NYSE: STJ) is acquiring the remaining 81 percent of CardioMEMS, Inc. it does not own for $375 million


CardioMEMS sold to St. Jude Medical: Boston Millennia Partners announced that St. Jude Medical (NYSE: STJ) is acquiring the remaining 81 percent of CardioMEMS, Inc. it does not own for $375 million

Reporter: Aviva Lev-Ari,  PhD, RN

 

UPDATED on 6/3/2014

 

Boston Millennia Partners announces the sale of its portfolio company CardioMEMS to St. Jude Medical

Boston, MA – June 3, 2014

Boston Millennia Partners is pleased to announce that St. Jude Medical (NYSE: STJ) is acquiring the remaining 81 percent of CardioMEMS, Inc. it does not own for $375 million.

Dana Callow, Managing General Partner at Boston Millennia Partners, said, “We congratulate the management team of CardioMEMS for the recent FDA approval of the company’s remote heart monitoring device. We agree with the belief of many cardiology experts that the CardioMEMS HF System represents the most significant advancement in the treatment of congestive heart failure in the past twenty years. With the subsequently announced acquisition of CardioMEMS by St. Jude Medical, this device will receive broad distribution and improve the lives of patients worldwide.

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. “The approval of the CHAMPION Heart Failure Monitoring System is a significant event for both patients and for those who pay for healthcare. Avoiding unnecessary hospitalizations and reducing the risk of acute decompensation in patients with this chronic disease benefits everyone”, said Pat Fortune, Venture Partner at Boston Millennia Partners.

About CardioMEMS

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, Boston Millennia Partners and Foundation Medical Partners. For more information, please visit http://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.

SOURCE

http://campaign.r20.constantcontact.com/render?ca=a5d4772f-7673-449c-9b09-2bb48d802dc6&c=6407cc90-31f8-11e3-946e-d4ae527b895a&ch=64ad3450-31f8-11e3-959c-d4ae527b895a

FDA News Release

FDA approves first implantable wireless device with remote monitoring to measure pulmonary artery pressure in certain heart failure patients

For Immediate Release

May 28, 2014

Release

The U.S. Food and Drug Administration today approved the CardioMEMS HF System that measures the pulmonary artery (PA) pressures and heart rates of patients with New York Heart Association (NYHA) Class III heart failure who have been hospitalized for heart failure in the previous year. The device allows health care professionals to monitor the condition of their patients remotely.

About 5.8 million people in the United States have heart failure, a condition in which the heart cannot pump enough blood to meet the body’s needs. With proper treatment and lifestyle changes, people with heart failure can live longer and more active lives. The NYHA Functional Classification further defines the extent of heart failure in patients. Patients with Class III heart failure experience marked limitation in physical activity, even during less-than-ordinary activity such as walking short distances.

The CardioMEMS HF System is used by the patient in the home or other remote location. This is the first permanently implantable wireless system intended to provide PA pressure measurements, including systolic, diastolic and mean PA pressures. The PA pressure data are reviewed by physicians who can make decisions regarding the status of the patient and, if necessary, initiate changes in medical therapy, with the goal of  reducing hospitalization due to heart failure.

The system consists of three parts:

  • A battery-free Implantable Sensor/Monitor implanted permanently in the PA;
  • Delivery System, a transvenous catheter designed to deploy the Implantable Sensor, within the distal PA; and
  • CardioMEMS Hospital and Patient Electronics Systems where the Electronics System acquires and processes signals from the Implantable Sensor/Monitor and transfers PA pressure measurements to a secure database.

“Heart failure is one of the most common reasons for hospitalizations for people aged 65 and older,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The goal of this first-of-its-kind implantable wireless device with remote monitoring of pulmonary artery pressure is to reduce heart failure-related hospitalizations.”

To support the approval, the company submitted data from its pivotal clinical study. Concerns about the clinical study were discussed at the December 8, 2011 meeting of the Circulatory System Devices Panel of FDA’s Medical Devices Advisory Committee. The company provided additional follow-up data and analyses that were discussed at the October 9, 2013 meeting of the Circulatory System Devices Panel to address these concerns.

The clinical study, in which 550 participants had the device implanted and were randomized into either the control group or investigational group, showed a clinically and statistically significant reduction in heart failure-related hospitalizations for the participants whose doctors had access to pulmonary artery pressure data. Of the participants who had the device implanted (or in whom there was an attempt to implant the device), 98.6 percent were free from device/system-related complications at six months. Of the devices implanted, 100 percent were operational at 6 months, and there were no device explants or repeat implants during this time period.

The FDA believes that there is reasonable assurance that the device is safe and effective for heart failure management with the goal of reducing the rate of heart failure-related hospitalizations in certain patients. The FDA is requiring a thorough Post-Approval Study to continue to learn about the device’s performance when used outside the context of a clinical study.

The CardioMEMS HF System is manufactured by CardioMEMS, Inc., located in Atlanta, Ga.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE

 

 

cardiomems

The FDA recent approval of a heart failure monitoring device will allow physicians to check up on patients’ health remotely. Intel Free Press, CC BY-SA 2.0

The Food and Drug Administration (FDA) announced Thursday its approval for the first wireless implantable device, known as CardioMEMS HF System, designed to monitor the health of heart failure patients remotely.

Manufactured by CardioMEMS Inc., located in Atlanta, Ga., the device is meant to give health care professionals an early look at pulmonary artery (PA) pressure data, which they can use to change medication dosage or treatment method before the need for hospitalization. In the clinical study leading up to the FDA’s approval, 98.6 percent of subjects using the device saw no device-related complications within six months, and, of the devices implanted, 100 percent were operational within the same timeframe.

“Heart failure is one of the most common reasons for hospitalizations for people aged 65 and older,” said Christy Foreman, director in the FDA’s Center for Devices and Radiological Health, in the news release. According to the Centers for Disease Control and Prevention, roughly half of all people who develop heart failure die within five years of diagnosis, straining the national economy to the tune of $32 billion annually.

Heart failure occurs when the heart is no longer able to pump enough blood and oxygen to the surrounding parts of the body. While this doesn’t mean the heart necessarily stops beating altogether, the pulse it sends is too weak to replenish major organs. In typical cases, the blood that would normally leave the heart through the aorta never exits the muscle, recycling back into the heart and pooling in the surrounding valves. In congestive heart failure cases, blood may pool in other major organs as well.

The new device is intended to monitor the pressure of this outgoing blood. If the data shows the pressure is too low, physicians located remotely can check up on patients to gauge their health. Not all heart failure patients qualify for the device, the FDA explains. Only people with New York Heart Association (NYHA) Class III heart failure, who have been hospitalized for heart failure in the previous year, are eligible.

SOURCE

 

One Response

  1. Justin
    Justin Pearlman
    Chief of Cardiology at UCLA/KMC affiliate

    The device monitors pulmonary pressure, so one would think its strongest value would be for monitoring effectiveness of treatment for pulmonary hypertension, and that may indeed prove true, but it is not the target the company pursued. They followed the Sutton law and went were the money is, the much more prevalent condition, heart failure. Heart failure can be viewed as having backward and forward failure components. Backward failure, or pulmonary congestion, elevates pulmonary pressures and a skilled clinician can read the level on physical examination as “central venous pressure (CVP )” or “jugular venous pressure” by measuring the vertical (anti-gravity) distance from the zero point of mid atrium (4th intercostal space mid thorax) to the highest level of contiguous transmission of atrial and ventricular pulsations in the neck. This device in essence reports the CVP which reflects the adequacy of diuretic dosing for patients without significant lung, pulmonary valve or right ventricle disease. However, multiple studies have shown that correction of CVP affects symptoms, not longevity. For patients who cannot track orthopnea (how many pillows upper chest elevation are needed to alleviate shortness of breath) or edema (depth of leg swelling), or daily swings in body weight, this invasive implant can facilitate decisions about when to skip the diuretic (“water pill”), which may improve comfort and walking distance but cannot be expected to improve lifespan.
    Like Reply privatelyDelete 2 days ago

    Aviva Lev-Ari, PhD, RN
    Scientific & Biotech Conferences – Scientific Press Coverage at Leaders in Pharmaceutical Business Intelligence

    Dr. Pearlman,
    Thank you for the comment.
    It allows for remote MD monitoring of HF patient condition and drug adjustment of shorter interval than Office Visit.
    In light of the new trends related to Remote health management, Apple and Qualcomm are to announce hand held devices reporting PCPs diagnostics test result and drug dosage adjustment – the CardioMEMS, is more complex than Vitals.
    Delete 2 days ago



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