Is there a Market for Wireless Cardiac Monitoring Implants?

Full article reprinted from Start Up - December/January 2010

Transoma, which was developing an implantable ECG monitor for continuous, wireless arrhythmia monitoring closed its doors in December. Before that, Medtronic failed to gain FDA approval for an implantable hemodynamic monitor for heart failure. That's two strikes; what will it take for companies with implants for wireless monitoring to stay in the game? Jay Yadav, MD, of CardioMEMS gives his opinion. Read more...

Is there a Market for Wireless Cardiac Monitoring Implants?

Full article reprinted from Start Up - December/January 2010

In December, Transoma Medical Inc. went bust, ending a long list of companies to run out of funding and close their doors in 2009. To what extent was its demise a consequence of the generally poor investment climate, versus the result of trying to sell an implantable device for a diagnostic, not therapeutic purpose?

Transoma had raised more than $40 million in venture capital to support a business in wireless cardiac monitoring. The company was spun out of Data Sciences International Inc., which still runs a profitable business in providing wireless monitoring implants for animal research. Transoma developed and gained FDA clearance for a wireless monitoring system to detect arrhythmias and syncope (unexplained and sudden fainting). Its system consisted of an implantable ECG monitor, called Sleuth AT, a small hand-held device that automatically retrieved data from the implantable sensor and sent it to a base station, which relayed the data to a third-party monitoring center where cardiac technicians reviewed data and alerted the patient's physician as necessary. The idea was to automatically provide continuous monitoring to patients to catch episodes of erratic and unpredictable heart arrhythmias, often missed during office-based diagnostic tests or courses of Holter-monitoring.

After bearing the high costs of developing an implantable device, with all its safety and reliability requirements, Transoma reportedly ran up losses while trying to establish its wireless monitoring business which, with an implantable device and a 24/7 service center, couldn't help but be an expensive offering. Transoma's several thousand dollar price points approached those of pacemakers, but pacemakers collect diagnostic information and deliver therapy. Indeed, more than ever, resistant reimbursement agencies are unwilling to pay high up-front costs to implant diagnostic or therapeutic devices that provide uncertain benefits in an uncertain time frame. Thus the question: Is there a market for implantable devices that provide wireless monitoring?

CardioMEMS Inc. continues to argue that there is--at least in heart failure--and so far the company's investors agree. Even in this shaky investment climate, its investors brought the company an additional $22.1 million in 2009, bringing the total raised in six financing rounds to more than $108 million.

Heart failure is one disease in which providing the right information to the physician at the right time can have an enormous clinical and financial impact. It is responsible for $35 billion in costs to the health care system, with $20 billion of that due to hospitalizations from episodes of decompensated heart failure. It is Medicare's stated goal (and that of the American College of Cardiology) to reduce heart failure hospital admissions by 20% by 2012. And according to interventional cardiologist Jay Yadav, MD, the founder of CardioMEMS, there's both the need and the ability to get the information necessary to prevent patients from ending up in the hospital, and for managing them better. There are plenty of good drugs for heart failure, he points out: what's missing is the information to help physicians adjust them in a timely fashion to keep patients healthy.

The most relevant piece of information for the management of patients with heart failure is intracardiac pressure, Yadav says, and today there is only one way to get that: right heart catheterization. "So we always adjust medications on the basis of clinical symptoms, which are notoriously inaccurate." Indeed, there are heart failure monitoring companies that look for heart decompensation trends based on a patient's weight, but that is more of a late warning system than an early one. Intracardiac pressure is the right measurement, he says.

Yadav says that physicians' desire to adhere to the principle of "Do No Harm," results in patients typically being undermedicated. "We find they are running very high intracardiac pressures, but nobody knows it." That's why CardioMEMS developed a tiny, permanent, implantable sensor that monitors pulmonary artery pressure and cardiac output. It's a tiny sensor that is implanted in a branch of the pulmonary artery, and it doesn't require batteries (it absorbs radiofrequency energy from an external electronics module). The sensor communicates wirelessly with an external device -- a wand which a patient waves over his body for about 20 seconds to collect data from the device. Every morning, the patient takes a reading, it goes to CardioMEMS' servers, and health care providers can then get information from a secure web site to adjust medications accordingly to keep pressures as close to a physiologic range as possible, says Yadav.

This was the same goal that Medtronic Inc. had with its Chronicle device in heart failure, except that it failed to get reimbursement, even after showing payors what it saw as an overwhelmingly positive clinical trial. Chronicle was designed to continuously measure heart rate, pressure in the heart, body temperature, and other physiologic signs to help physicians predict impending episodes of decompensation and intervene in time. Medtronic's clinical trial COMPASS-HF demonstrated that use of Chronicle resulted in a 22% reduction in hospitalizations or visits to emergency rooms. Nevertheless, in March 2007, the FDA rejected Chronicle, for insufficient clinical effectiveness.

Yadav gives credit to Medtronic for being the pioneer in the space, and says CardioMEMS has been able to learn from the large company's experience. For one thing, CardioMEMS decided to use a much large sample size in its clinical trial. It just completed enrollment of 550 patients, compared to the 275 patients in the COMPASS-HF trial. Yadav also says that in the CardioMEMS trial, information is transmitted daily, whereas Medtronic only transmitted once per week. Finally, the CardioMEMS endpoints are slightly different: Medtronic used a composite endpoint consisting of heart failure hospitalizations as well as emergency room and urgent clinic visits requiring intravenous intervention, while CardioMEMS will simply look at heart failure hospitalizations.

As part of the clinical trial, CardioMEMS is also doing a cost-effectiveness study to help make the case for reimbursement, a task that is made easier by the fact that the primary clinical endpoint of the study is also cost related. "Heart failure hospitalization has a clear cost associated with it," he says. "By attacking that piece of it, we will hopefully be able to demonstrate both the clinical and financial benefits to the system." Yadav expects trial results to be available in the early part of next year.

Historically diagnostics aren't priced as high as therapies—nor are they reimbursed as highly either, so one problem continuous monitoring companies face, particularly those with implantable devices, is the high cost of their offering and a reluctance on the part of payers to reimburse sufficiently for it. CardioNet Inc., in wireless arrhythmia monitoring doesn't have an implantable component, but it has faced just this problem of insufficient reimbursement. (See "Wireless Health: Personalized Medicine Comes to the Device Industry," START-UP, October 2009.)

Yadav says that although CardioMEMS is providing a monitoring technology, its clinical trial has a therapeutic endpoint. But in any case, he says, the distinctions between diagnostics, monitoring and therapy have to change. "The FDA isn't asking us to show that we can measure pressure. We did that a long time ago. They are asking us to show a clinical benefit to the patient."

"Information can be extremely therapeutic," he goes on. "If CardioMEMS helps to shift a patient from Class II to Class II heart failure, how is that different from a CRT [cardiac resynchronization therapy] device?"

--Mary Stuart

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Companies mentioned in this article:

CardioMEMS Inc.

CardioNet Inc.

Medtronic Inc.

Transoma Medical Inc.
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No publication reviews leading edge companies and technology better than START-UP. Each issue of START-UP profiles the most important new product companies, identifies the hottest technology areas, reviews funds flowing into private companies and investment trends, and reports on university tech transfer licensing. Industries covered: pharmaceuticals, biotechnology, medical equipment & devices, and in vitro diagnostics.