St. Jude Medical probably thought it had a couple of homeruns with Nanostim, the world’s first commercially available leadless pacemaker, and the CardioMEMS HF system for remotely monitoring heart failure patients. But while there’s no doubt both of these devices are pushing the envelope when it comes to innovation, they have experienced a few setbacks.
Nanostim, which received the CE Mark back in 2013, halted sales in Europe last year after a postmarket study revealed patient deaths and other adverse effects associated with the technique used to implant the device. Meanwhile, competitor Medtronic launched an even smaller leadless pacing product, the Micra.
CardioMEMS, which has an average selling price of nearly $18,000, has faced criticism for being too expensive. Although St. Jude medical director Phillip Adamson defended the cost of CardioMEMS, the company announced in its third quarter earnings call that sales have been slower than expected.
|Start 2016 off right by attending MD&M West, the world's largest medical design and manufacturing event, February 9-11, at the Anaheim Convention Center.|