REGULATORY NEWS FROM THE US AND EUROPE

Products That Have Received Approval from FDA and CE

Medtronic have received FDA approval to launch its Attain Performa Model 4298 quadripolar lead and the Viva Quad XT and Viva Quad S cardiac resynchronization therapy defibrillators (CRT-D) into the US.

Having four electrodes on a lead gives cardiologists the option to select from up to 16 possible pacing configurations. The device also reduces the incidence of phrenic nerve stimulation (PNS).

SynCardia’s Total Artificial Heart with SynHall valves has been approved for use in the US. SynCardia now has all the required approvals to manufacture the hearts and sell them in the US. The device has already been approved for the Candian and European markets.

U.K firm PlaqueTec has recently received CE Mark approval for its Liquid Biopsy System, which is the first of its kind. The Liquid Biopsy System, is used in conjunction with standard catherization equipment found in a laboratory. It allows the doctor to take blood samples near a legion, simultaneously from both above and below the targeted site. This provides doctors with better data than standard practices allows. Analysis of biomarkers from the blood samples permit the doctors to assertain the risk of the pateint suffering a fatal heart attack.