Physicians at this year’s European Society of Cardiology meeting in Paris called for an overhaul of Europe’s CE Mark medical device approval process, calling it too lax in review of potentially dangerous products.
Medical device makers have chided the FDA for inefficient review of new technologies and Congress has asked the watchdog agency to review Europe’s less stringent process for opportunities to revamp the system at home, but doctors had harsh criticism for the CE Mark pathway, saying it uses the same structure to review pacemakers and electric toasters.
Life-saving devices can hit the market faster in Europe where clinical testing is generally done after approval, unlike in the U.S. where high-risk devices more frequently undergo a battery of clinical trials to prove safety and effectiveness prior to being allowed on the market.
“Where there have been isolated instances of devices that were associated with complications, those have disproportionately occurred in countries that have earlier approval — and that tends to be Europe,” Cardiff University cardiologist Dr. Alan Fraser who led a E.U. regulatory review panel at the ESC meeting told Reuters.
Here’s a roundup of recent clinical trial and scientific study news from the ESC 2011 conference:
As more patients receive implantable cardioverter defibrillators the number of patients with infections related to their ICDs grows, a situation that is complicated by an increasingly older population with comorbidities and increased heart failure that push infection risks even higher.
Confirmed infections require complete removal of all pieces of the device, a procedure done in specialized centers.
"The extraction is a battle that requires a wonderful general, a great army, and a careful strategy," she said. "And a little bit of good luck in some situations," panel presenter Dr. Maria Grazia Bongiorni of the University Hospital of Pisa, Italy said.
Patients with urgent but stable heart failure should avoid ventricular assist implants, according to data gathered from the Spanish National Heart Transplant Registry.
Drug-eluting stents proved better than bare-metal stents in one-year clinical outcomes, including for in-stent thrombosis, target lesion revascularization, and target vessel revascularization.
Stereotaxis, Inc. (NSDQ:STXS) unveiled results from the first-ever, prospective multicenter evaluation of magnetic navigation for ventricular tissue ablation with a 94 percent acute success rate.