
MASSDEVICE ON CALL — The medical device industry and the FDA’s Center for Devices & Radiological Health need to get their heads together to improve the med-tech approval process while ensuring patient safety, according to Se. Al Franken (D-Minn.).
"These people better start talking to each other," Franken told the Minneapolis Star-Tribune yesterday. "I want to be a bridge."
Back in the Land of 10,000 Lakes while Congress is in recess, Franken said the issue isn’t a simple either/or equation.
"To some degree, there is a false choice there," he told the newspaper, noting
that his effort to bring CDRH chief Dr. Jeffrey Shuren to Minnesota for a med-tech tète-a-tète led to a new regulatory sciences partnership between the agency and the industry. Even though the issue involves "pretty complex stuff," Franken said, streamlining the federal watchdog agency and improving the climate for med-tech should go hand in hand.
"The longer things take to get to market, it makes the thing not cost-effective to do in the first place," Franken said Thursday. "There are people who need these devices."
A provision in a Senate medical device bill introduced by the former Saturday Night Live star are aimed at making it easier for the FDA to work with experts in reviewing new medical technology for clearance or approval. Another Franken introduction to the bill would remove a bar preventing devices developed for treating rare diseases from being commercialized, according to the Star-Tribune.
BoTox is 10 years old
Allergan (NYSE:AGN) is touting the 10-year anniversary of the FDA’s approval of its BoTox onabotulinumtoxinA injection to treat frown lines.
"When approved by the FDA in 2002, BoTox Cosmetic changed the way that physicians could treat patients who were interested in improving the appearance of their vertical frown lines between the brows," chairman president & CEO David Pyott said in prepared remarks. "BoTox Cosmetic has become the number-1 neuromodulator in the U.S. and the number of patients considering talking to their doctor about treatment has more than quadrupled to 5.8 million since 2002."
Experts weigh in on Mass. health care reform after 6 years
Experts ranging from Mass. Gov. Deval Patrick to Dr. Lynda Young, president of the Mass. Medical Society, are weighing on the Bay State’s pioneering health care reform 6 years down the road.
The experiment has indelibly changed how the Commonwealth’s physicians practice medicine, Young writes.
"Even if the Supreme Court overturns the federal health law, health care delivery in the U.S. will never be the same. Accountable care organizations are here to stay. Electronic health records won’t go away, and they will get better and better. Hospitals, physicians and other health care providers are working together more, and market consolidation is occurring under our feet. The Affordable Care Act merely hastened the process, and added momentum to the changes we’ve been seeing in Massachusetts, too," she writes. "Will our experiences in Massachusetts be the same as physicians in other states? Maybe not. Health care delivery can be a local phenomenon, so experiences are bound to vary. But for us in Massachusetts, we are keenly aware that while health reform still presents many challenges, its benefits are very tangible."
Medtronic launches drug-eluting balloon study
Medtronic (NYSE:MDT) launched a study of its In.Pact drug-eluting balloons, with the first patients treated at hospitals in California and Indiana.
InVivo to pursue HDE for biopolymer spinal cord scaffold
InVivo Therapeutics (OTC:NVIV) said it expects to pursue a humanitarian device exemption as part of its application for an investigational device exemption from the FDA after meeting with the federal watchdog agency’s Center for Device’s & Radiological Health.
Study: CT cross-section ahead of TAVI reduces regurgitation
A study shows that obtaining a CT scan cross-section of the aortic valve before selecting a replacement valve size dramatically reduced the incidence of regurgitation post-procedure, an outcome that raised red flags at the recent annual meeting of the American College of Cardiology when Edwards Lifesciences (NYSE:EW) presented data from its Partner A trial of its Sapien transcatheter aortic valve implant.