FDA APPROVES TWO DEFIBRILLATORS

The FDA Aug. 17 posted to its website an Aug. 10 approval letter for the Tupos LV/ATx and Kronos LV-T cardiac resynchronization therapy defibrillators (CRT-Ds) and the Corox OTW Steroid Lead, manufactured by Biotronik.

Tupos LV/ATx and Kronos LV-T CRT-D consist of four separate components: a titanium can containing a battery and electronic circuitry that provides multiple therapies, and three insulated lead wires that connect the defibrillators to the patient's heart, including the Corox OTW Steroid left ventricular pacing lead.

When the CRT-D senses dangerous abnormal heart rhythms it shocks the heart into a normal rhythm and prevents sudden cardiac death.

The approval letter can be viewed at www.fda.gov/cdrh/pdf5/p050023a.pdf (http://www.fda.gov/cdrh/pdf5/p050023a.pdf).