FDA Blesses St. Jude Medical’s CardioMEMS Device To Treat Heart Failure

After rejecting it the first time, FDA has approved the world’s first implantable wireless heart monitoring device to manage chronic heart failure patients remotely.

Though approved, FDA is requiring a post-approval study to see how the CardioMEMS HF System performs outside of clinical trials.

In a clinical trial with 550 patients, the CardioMEMS device implanted on the pulmonary artery showed a 28% reduction in the heart failure hospitalizations at six months, and a similar 37% reduction during an average, 15-month follow-up period, according to St. Jude Medical, which is buying CardioMEMS.

St. Jude Medical had an 19% equity stake in Atlanta-based CardioMEMS since 2010 for $60 million, but is acquiring the company through an exclusive option. It will exercise its option to buy CardioMems immediately for $375 million and the deal will close by the second quarter.

“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,” said Eric Fain, group president of St. Jude Medical, said in a statement.

Chronic heart failure is an expensive, chronic disease, and hospitals are trying many different ways to manage their heart failure patients better at a time when Medicare penalizes hospitals for readmitting these patients within 30 days of a discharge.

“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,” Fain declared. “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" Fain said.

The statement shows how St. Jude Medical and its in-state rival Medtronic have adopted two different approaches to managing chronic heart failure. Medtronic has opted for telemedicine and remote patient monitoring through its acquisition of CardioCom and rumored acquisition of Corventis, which makes a wearable, noninvasive device that monitors fluid build up, an indicator of worsening heart failure condition.

On the other hand, St. Jude Medical has doubled down on an invasive, implantable solution to manage these patients. Now hospitals and physicians need to figure out which approach will be the winning solution both in terms of cost and clinical effectiveness.

Medicare reimbursement is already in place for the CardioMEMS device, but St. Jude Medical is hoping to get a new technology add-on coverage, wrote Glenn Novarro, in a research note following the FDA announcement Wednesday. St. Jude Medical has previously estimated that in 2014, sales of the CardioMEMS device will be $15 million to $20 million, he added.

“We note that expectations for peak sales is much larger, as management has publicly commented on $1B+ opportunity on the back of epidemiological models,” Novarro wrote.

-- By Arundhati Parmar, Senior Editor, MD+DI
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