Tiny cardiovascular devices made by Medtronic and Abbott Laboratories' St. Jude Medical unit may get a big boost from positive new data presented over the weekend at a major industry conference.
At the American College of Cardiology's annual expo in Washington, D.C., Minnesota-run Medtronic revealed the first official data from its closely watched Surtavi trial. The results may eventually lead to more elderly patients becoming eligible to get one of the company's hot-selling minimally invasive heart valves.
St. Jude, meanwhile, unveiled yet more data at the ACC's 66th annual Scientific Session and Expo on its CardioMEMS implantable pulmonary blood-pressure monitor. The data from "real world" practice backed up findings in an earlier clinical trial that showed the device can greatly reduce expensive hospitalizations caused by advanced heart failure. Thus far, the device has not lived up to its commercial promise, despite strong clinical data.
Medtronic's Surtavi data, which was simultaneously published Friday in the New England Journal of Medicine, attracted considerable industry notice for its finding that intermediate-risk patients who received the company's new foldable, catheter-delivered heart valves for stenosis of the aorta had comparable rates of death and stroke as patients treated with traditional open-heart valve procedures.
The new valves, which are implanted via incision in the leg, are already approved in the United States for patients who face high surgical risks or are considered inoperable for their stenosis. Friday's data showed Medtronic's minimally invasive CoreValve and Evolut R valves were just as safe as surgery in patients considered to be at "intermediate" risk of problems from heart surgery.
Specifically, the rate of all-cause death or disabling stroke two years after the procedure was 12.6 percent for the new transcatheter aortic valves, vs. 14 percent for traditional valves implanted with open-chest surgery.
The randomized, controlled prospective trial examined 24 months of data from 1,660 patients with a mean age of 79.9. Although the overall risks of death and stroke were statistically similar, the study found traditional surgery had higher rates of acute kidney injury, atrial fibrillation and transfusions, while the transcatheter-valve population had more residual aortic regurgitation and a greater need for pacemakers after implant.
"We observed excellent outcomes in both arms of the study and were pleased to see the self-expanding [minimally invasive] platform perform as well as the gold standard of surgery in this intermediate risk population," Surtavi principal investigator and Houston heart surgeon Dr. Michael Reardon said in a statement.
Analysts with Leerink Partners said in an investors' note that the data seem to validate the idea of widespread acceptance of transcatheter valve procedures in intermediate-risk populations. However, analysts' expectation for quick growth in the intermediate population may have been too optimistic, given the Surtavi team's finding that the patients who benefit most from the transcatheter mortality rates are the highest-risk patients, not those at intermediate risk.
St. Jude Medical was active at the meeting as well, rolling out a total of five papers and posters on its CardioMEMS system.
CardioMEMS is a novel battery-free device that monitors blood pressure in the pulmonary artery and wirelessly transmits the results to a bedside monitor, which sends the data along to a doctor's office. Data from the device helps doctors adjust a patient's medications based on pulmonary artery pressure before the onset of symptoms that would prompt a hospital visit.
On Sunday, researchers presented the results of a study of medical records of 1,100 Medicare patients that found a 34 percent reduction in hospitalizations for heart failure within one year of a patient getting a CardioMEMS device implanted, translating into a reduction of $13,000 in hospitalization costs per patient in that time. An earlier project known as Champion trial found similar results in a controlled clinical setting.
The U.S. Food and Drug Administration approved the device in 2014, but insurers and Medicare have remained somewhat skeptical about the device's value proposition.
In late 2015, a panel of doctors and medical experts convened by not-for-profit Institute for Clinical and Economic Review found that CardioMEMS represented "low care value" given its incremental benefit and its Medicare list price of $17,750 at the time. ICER is funded largely by insurance companies and health care foundations.
"Our view remains that CardioMEMS has the potential to be an important tool in managing patients with HR," stock analysts with SunTrust Robinson Humphrey wrote this month, "but also that inroads on the reimbursement front remain paramount to broad commercial adoption."
Joe Carlson • 612-673-4779
