News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Implantable devices with this technology could be designed to perform some of the same kinds of assays currently handled in medical labs

Implantable diagnostic devices that report results wirelessly to patients’ physicians could be both a threat and an opportunity for clinical laboratories and pathology groups. News of clearance by the Food and Drug Administration (FDA) of an implantable monitoring device for home use by heart patients demonstrates that such technology is improving with rapid speed.

Could Implantable Monitoring Devices Replace Some Medical Lab Tests?

Patients use CardioMEMS from the comfort of their homes. The implantable monitoring device measures pulmonary artery pressures and heart rates and transmits that data wirelessly to physicians. It was last summer when the FDA cleared the CardioMEMS Heart Failure Management System, manufactured by St. Jude Medical of St. Paul, MN. Such implantable technology could eventually perform certain assays currently handled in medical laboratories.

At a time when the healthcare system wants to keep people out of the hospital, the clinical study of the device showed a substantial reduction in the rates of readmissions among the patients involved in the study. Pathologists should take note of this achievement. The success of this implantable device—and its FDA clearance—will encourage more efforts to develop implantable devices that perform some of the same diagnostic tests. In this sense, the era of in vivo diagnostics might be around the corner.

St. Jude Medical’s retrospective data analysis from the CHAMPION (CardioMEMS Heart Sensor Allow Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) clinical trial showed a 58% drop in all-cause readmissions and a 78% reduction in heart failure 30-day readmissions in patients 65 and older. The analysis was presented during the 2014 American Heart Association Scientific Sessions.

For One Class of Patients, Hospital Readmissions Declined 37%

The FDA gave the CardioMEMS System the green light to manage heart failure in NYHA Class III heart failure patients in May 2014 based on CHAMPION clinical trial data. The study, in which 550 participants had the device implanted, showed a clinically and statistically significant reduction in heart failure-related hospitalizations for participants whose doctors monitored their pulmonary artery pressure data remotely. There was a 37% reduction in hospitalizations when the system was used for an average of 15 months.

“Health 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, in an FDA press release. “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.”

The CardioMEMS HF System enables healthcare providers to remotely monitor a patient’s pulmonary artery pressures and proactively manage medications and other treatment options. The device is approved for use with a specific group of heart disease patients—NYHA Class III, which results in a marked limitation in physical activity—who have been hospitalized for heart failure in the previous year.

Battery-Free Artery Pressure Monitoring

The CardioMEMS System measures pulmonary artery pressure using a battery-free miniaturized monitoring sensor that is implanted in the pulmonary artery during a minimally invasive procedure. At home, patients turn on a portable monitoring unit and submit daily sensor readings to their healthcare providers by lying on a special pillow that contains an antenna. Pressure readings takes about 20 seconds each and are wirelessly transmitted to a secure website where the patient’s clinician can view them.

“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,” stated Lynne Warner Stevenson, M.D., Director of the Heart Failure Program at Brigham and Women’s Hospital in Boston, said in a St. Jude Medical press release.

Reducing hospital readmission rates has taken on added significance since the U.S. Centers for Medicare and Medicaid Services (CMS) began reducing Medicare reimbursement rates to health systems with high 30-day readmission rates for patient cohorts such as heart failure, heart attack, pneumonia, obstructive pulmonary disease, and total hip/total knee arthroplasty. In fiscal year 2015, the maximum penalty rose to 3%.

New Monitoring System Helps Physicians Be Proactive with Patients

Philip B. Adamson, M.D., FACC, Director of the Heart Failure Institute at the Oklahoma Heart Hospital in Oklahoma City, and co-investigator on the CHAMPION clinical trial, believes the CardioMEMS HF System introduces a much-needed new paradigm for heart failure patient management.

Philip B. Adamson, M.D

Philip B. Adamson, M.D., Director of the Heart Failure Institute of the Oklahoma Heart Hospital in Oklahoma City, was one of the first physicians to implant the CardioMEMS HF System, the first and only FDA-approved heart failure monitoring device proven to significantly reduce hospital admissions when used by physicians to manage heart failure. It is used by patients at home and wirelessly transmits data. (Photo copyright Oklahoma Heart Hospital.)


“This concept of reactive heart failure management—waiting until patients get symptoms or waiting until their weight changes, which doesn’t happen as often as we think it should when patients gain fluid—is an inefficient way to manage the disease and actually leads to the pandemic of hospitalizations that we see in our current society,” said Adamson in a CardioMEMS HF System webinar on the St. Jude Medical website.

There are an estimated 5.9 million Americans living with heart failure, a diagnosis that leads to one million hospitalizations and 2.8-million office and emergency department visits each year.

“If one looks at conservative estimates of how many patients will have heart failure in the future, we expect to have more than a doubling of patients with this disease by the year 2030,” Adamson said.

ABI Research, a New York-based market research and intelligence firm, estimates nearly 100 million wearable RPM devices will be shipped during the next five years. In North American, an aging population and mounting lifestyle diseases are driving growth in the patient monitoring device market.

CardioMEMS Market Is Huge, Compared to Individual Clinical Lab Tests

Clinical lab managers should take note of that estimate of market size. A lab test that is performed 10 million times per year is considered a big winner by in vitro diagnostics manufacturers. Here is an implantable heart monitoring device with a market potential of 20 million units shipped per year!

Another sign of clinical acceptance for the concept of implantable devices with wireless transmission of data is the fact that CardioMEMS also has been approved for a New Technology Add-On Payment by the Medicare program. This means CMS will reimburse hospitals an incremental amount above the Medicare Severity Diagnosis Related Group (DRG) payment.

It’s important to note that this clearance is for a specific disease and under specific conditions. At the same time, CardioMEMS’s clinical trial convinced the FDA of the device’s value in monitoring the patients and triggering fast intervention as appropriate.

Opportunities for In Vitro Diagnostics Manufacturers

Companies developing new clinical laboratory tests may want to take note of how the design of the clinical study of the CardioMEMS device included a detailed analysis of the decline in hospital readmissions of this target group of heart patients. Such data appears to have convinced the FDA to clear the device for marketing and for CMS to make a favorable decision on coverage for the implantable device.

—Andrea Downing Peck

Related Information:

Wireless Patient Monitoring and Diagnostic Systems Using MBANs Should Be on the Radar Screens of Pathologists and Clinical Laboratory Professionals

Data Shows CardioMEMS HF System Significantly Reduced 30-Day Hospital Readmission Rates 

CardioMEMS Gets FDA Approval For Implanted Artery Pressure Sensor, St. Jude to Acquire IT 

CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) Trial 

The Remote Patient Management Revolution: Wearable Devices and Open Management Platforms