The OmniaSecure defibrillation lead from Medtronic is already approved for placement in the right ventricle. This latest approval covers the left bundle branch area, opening the door for conduction system pacing and other advanced techniques.
The COVID-19 pandemic created a major shift in how telehealth services were being utilized. Those services were used much more often for some patient populations than others.
The incident left John Douglas Cox, a mechanic in Washington’s Clark County, partially paralyzed after physicians failed to promptly diagnose and treat a spinal infection.
CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.
The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.
