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Patients Call for Continued FDA Preemption Authority
Date:5/11/2009

g and enhancing their lives, and to speak out about protecting access to devices now and in the future. In addition to Laura Doud, medical device beneficiaries who attended the briefing include:

  • Adam Hammond, from Columbus, Ohio, a former U.S. Army Officer and Golden Knights parachutist who suffered life-threatening injuries when his parachute failed to open. He can now walk and function again without severe and debilitating chronic pain after receiving a neurostimulator.
  • Tom Price, a long-distance runner from Syracuse, New York, was unable to run more than a mile due to calcification and severe regurgitation in his bicuspid aortic valve. After aortic valve replacement, he has resumed his active lifestyle.
  • Mike Roman, from St. Louis, Missouri, a world-class race car driver who received a spinal cord stimulator to treat the constant, debilitating pain he felt after losing his leg to infection.
  • Olivia Vervaeke, a senior from Detroit, Michigan, graduating this week from the University of Notre Dame, born with a congenital heart defect that severely worsened in high school. Olivia required an implantable cardioverter defibrillator (ICD) in 2005.

The patients emphasized how critical it was for them to have access to devices when they needed them most.

"This device saved my life," said Olivia Vervaeke, who is graduating from college on Sunday, May 17 but took a break from wrapping up her final days at Notre Dame to come to Washington to tell her story. "I can run five miles a day now; I could never do that before."

"We should be working to strengthen FDA resources so more medical devices can be made and improved -- not make it more difficult for patients to access them," said Tom Price, who has run multiple half- and full-marathons less than two years after his aortic valve replac
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SOURCE AdvaMed
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