FDA looks to strengthen device surveillance post-Riata | MassDevice.com On Call

MASSDEVICE ON CALL — Under increasing pressure from doctors, the FDA this month will unveil a new medical device post-market surveillance program aimed at better tracking potentially faulty devices.

The more rigorous program will include unique device identifiers that allow the FDA, doctors and manufacturers to track individual devices and better monitor, track and report defects.

The renewed push for post-market safety comes in part from physician pressure following a study, authored by prominent cardiologist Dr. Robert Hauser and published last month, linking St. Jude Medical’s (NYSE:STJ) recalled Riata defibrillator lead with 22 deaths, the Wall Street Journal reported.

That study released a firestorm of controversy, with St. Jude now calling for a retraction based on its own parallel study finding that at least one of the study’s parameters was miscalculated.

"This has become a topic of competitive marketing," St. Jude CEO Daniel Starks told journalists. "We have competitors going to physicians and informing them, either incompletely or mistakenly, of a competitively hostile view of the facts."

Twin Cities arch-rival Medtronic (NYSE:MDT) told MassDevice.com yesterday that it, too, reviewed Hauser’s study and was able to corroborate certain findings.

"Numerous other institutions have issued case studies and manuscripts on this issue," Medtronic spokesman Christopher Garland told us. "This is very clearly not a marketing campaign; this is a serious issue with a device in the marketplace."

ICD-10 may be delayed a year

The Obama administration proposed a 1-year delay to the ICD-10 medical coding system, set to take effect Oct. 1, 2013, in order to give health providers "more time to prepare and fully test their systems to ensure a smooth and coordinated transition to these new code sets," the Wall Street Journal reported.

Hospitals demand Congressional refund if health reform’s mandate goes down

Hospital groups are seeking a $155 billion refund from Congress to reverse agreed-upon Medicare and Medicaid cuts that health providers say they can’t recoup should health care reform overall survive without the individual insurance mandate, Politico reported (paid).

Dental X-rays linked with benign brain tumors

A new study published in the American Cancer Society’s journal found that people with meningioma, a type of brain tumor that is almost always benign, were more than twice as likely as those without the tumor to have had a bitewing dental X-ray sometime in their lives, the Washington Post reported.

ReCor Medical unveils Paradise study results for resistant hypertension

ReCor Medical’s first-in-man Paradise study of ultrasound catheter renal denervation found that the therapy reduced systolic blood pressure "by a statistically significant amount" in patients with resistant hypertension, according to a press release.

TAVI "feasible" in patients with severe co-morbidities, study finds

A new study looking at transcatheter aortic valve implantation systems for patients with low-flow, low-gradient aortic stenosis as well as severe co-morbidities found high all-cause mortality within the first 6 months, but surviving patients "showed symptomatic benefit and significant improvement of myocardial function and exercise capacity," according to a study published in the April issue of the journal Catheterization & Cardiovascular Interventions.