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FDA panel concludes benefits of CarioMEMS’ remote monitoring device outweigh risks

9:55 am by | 0 Comments


Atlanta-based CardioMEMS Inc., developer of an implantable wireless device that helps physicians monitor blood pressure in heart patients, may be breathing a little easier following a federal panel's finding that another clinical trial shows its invention is safe.

It was a split decision, however, as the finding this week by the U.S. Food and Drug Administration's Circulatory System Devices Advisory Panel did not provide any indication as to whether the paper-clip size device is any closer to FDA approval. Efforts to reach a spokesman for CardioMEMS on Friday were unsuccessful.

It was the FDA panel's second split decision on the Champion HF Monitoring System, which wirelessly measures and monitors pulmonary artery pressure and heart rates in patients whose heart condition limits physical activity and breathing. Readings are sent to a database that helps physicians determine treatments -- for example, dosages of diuretics and nitrates, which can rapidly reduce pressure.

CardioMEMS was founded in 2001 by cardiologist Jay Yadav and Mark Allen, a Georgia Tech nanotechnology professor. It has grown from a small office near Georgia Tech to a large laboratory on Technology Circle in northwest Atlanta.


In 2011, the 11-member FDA panel found that while the wireless device was safe in clinical trials, a majority of panel members weren't convinced that it was effective or that the device's benefits outweighed its risks. The split decision was based partly on the finding that CardioMEMS nurses had advised physicians treating patients in a clinical trial of the device, which some FDA panel members felt compromised positive results.

According to an executive summary of the panel's follow-up analysis, the device is still safe and a majority of members were convinced the benefits of the device outweighed any risks. A majority on the panel, however, still felt the device had not been proven to be effective in overall treatment of patents in the trial. While it helped reduce hospitalizations, "the clinical significance is less clear," the report said.

According to the medical news site Healio.com, which cited several panel members, some were not convinced the second study was as thorough as it could have been, including the treatment effect on women. Others, however, found the device effective. Panel member Valluvan Jeevanandam called it "an excellent diagnostic tool."

The latest finding is considered good news for St. Jude Medical Inc., which owns 19 percent of CardioMEMS and has an exclusive right to purchase the company. One analyst, Danielle Antalffy of Leerink Swann, told MarketWatch that the FDA panel's finding makes it more likely the device will receive FDA approval. A St. Jude spokeswoman declined to comment to The Atlanta Journal-Constitution.

In August, Wells Fargo analyst Larry Biegelsen, who upgraded his buy recommendation on publicly traded St. Jude, said sales at privately held CardioMEMS could reach $259 million in 2017 if the device is approved, which would boost sales and earnings at St. Jude, assuming it exercises its option to buy the rest of the Atlanta company.

CardioMEMS has attracted more than $100 million in private investment and has received support from a state-backed nonprofit and about $700,000 from a publicly funded loan. ___

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By Christopher Seward

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