St. Jude Medical has halted implantation of its Portico transcatheter aortic valve replacement due to concerns about reduced valve leaflet mobility arising from the company's U.S. clinical trials. The CE-marked device is intended for patients with severe aortic stenosis who are at high risk or contraindicated for surgical aortic valve replacement.
St. Jude Medical's data dump at the European Society of Cardiology Congress in Barcelona, Spain, was heartening news for the company's products--especially those used to measure a ratio known as fractional flow reserve.
The U.S. Food and Drug Administration has picked up the pace on novel medical device approvals, but this year still may not hit levels seen in 2011 and 2012. During the first six months of 2014, the agency granted 17 premarket approvals, way up from 23 for the entirety of 2013.
Volcano didn't get investors to buy into the idea of short-term pain superseded by long-term gain. The intravascular imaging and peripheral device company reduced its guidance for the year and laid out a plan for the company that includes the divestiture of its Axsun business.
St. Jude Medical finalized its acquisition of interventional pain management therapy manufacturer NeuroTherm, gaining ground in a highly competitive neuromodulation market and expanding its chronic pain portfolio.
Venture capital company Boston Millennia helped close out St. Jude Medical's acquisition of CardioMEMS, a major device aquisition move to join several other important deals the VC finalized this year.
The second shift at St. Jude Medical's cardiology device manufacturing facility in Sylmar, a suburb of Los Angeles, is being eliminated, resulting in the loss of up 270 jobs. The layoffs will take effect July 28, reports the San Fernando Valley Business Journal.
St. Jude Medical is hoping to strengthen its franchise in ablation catheters--thin, flexible wires inserted non-surgically into the heart to treat cardiac arrhythmia. Its FlexAbility irrigated ablation catheter has garnered a CE Mark in Europe, where it has marketed the TactiCath contact-force sensing irrigated ablation catheter since 2012. The company hopes to get FDA approval by year end for both FlexAbility and TactiCath.
St. Jude Medical is celebrating positive second-quarter sales fueled by tried-and-true products, but the devicemaker wants to capitalize on an untapped niche in the coming year by focusing on renal denervation.
St. Jude Medical posted slight increases in second quarter sales, riding the tailwinds of recent M&A deals and the continued success of its cardiac rhythm management unit.