Dive Brief:
- Abbott has won approval for updated remote heart failure monitoring technology, the company said Friday.
- The Food and Drug Administration awarded approval to CardioMEMS Hero, a new version of the device that patients use to take daily pulmonary artery pressure readings.
- Abbott has made Hero smaller and 60% lighter than the previous reader, fitting the electronics into a device the size of a laptop case to make it easier to use and take on planes.
Dive Insight:
The CardioMEMS system comprises an implanted sensor and a reader. Patients lie on the reader to take pulmonary artery pressure readings and send the results to their care teams. Because rising pressures signal worsening heart failure, the results provide early warnings that can prompt patients to act, slowing disease progression and thereby avoiding hospitalization.
Abbott’s previous reader was too large to fit in a carry-on suitcase when flying, forcing patients to check a bag when traveling with the device by air. The company designed the smaller Hero to fit in a carry-on suitcase. Abbott said the smaller size will make the device easy to use day to day.
The company’s redesign is also intended to support a consistent reading position, which Abbott said will enable patients to provide reliable daily pressure trends to their care teams. Abbott has integrated Wi-Fi and cellular connectivity into the reader to make the device easy to set up and to allow patients to capture and share data from more locations.
Abbott will start selling Hero, which works with the current CardioMEMS sensor, in the U.S. soon. The launch could benefit from a reimbursement change enacted last year, when the Centers for Medicare and Medicaid Services issued a national coverage with evidence development determination for implantable pulmonary artery pressure sensors in heart failure management.
In January, Abbott CEO Robert Ford said on an earnings call that CardioMEMS contributed to 12% growth at the company’s heart failure franchise in the fourth quarter. The franchise supported another quarter of double-digit growth for Abbott’s medical device unit.
