It is the first PCI optimization system to offer OCT and angiography co-registration. It supports procedural decisions by providing high-resolution 3D OCT views of coronary anatomy while mapping the exact location of the current view via angiogram.
It also integrates the company's PressureWire fractional flow reserve measurement technology which provides hemodynamic information during PCI.
The FDA notifies St. Jude Medical (STJ +0.1%) that the issues cited in its warning letter regarding its Plano, TX manufacturing facility have been resolved. The agency issued the letter on June 26, 2009 after an on-site inspection identified cGMP non-conformities.
St. Jude Medical's (NYSE:STJ) Flexibility Ablation Catheter achieves CE Mark clearance in Europe. The product has a flexible tip that reduces complications associated with ablation procedures by conforming to the cardiac anatomy and reducing the amount of pressure to the cardiac wall.
St. Jude Medical (STJ -0.8%) enters into a definitive agreement to acquire privately-held NeuroTherm, a maker of interventional pain management therapies, for ~$200M in cash. The company expects to conclude the transaction in late Q3. NeuroTherm will add $10M - 15M to STJ's top-line sales in 2014.
The FDA approval of CardioMEM's HF remote cardiac function monitoring system prompts St. Jude Medical (STJ +3.6%) to exercise its option to buy the company for $375M. It acquired the option in 2010 when it invested $60M in the firm for a 19% stake.
Surgical teams at Los Angeles' Cedar Sinai Hospital and New York's Lenox Hill Hospital successfully implant St. Jude Medical's (STJ) Portico Transcatheter Aortic Heart Valve signifying the start of the PORTICO clinical trial. The product is fully repositionable until fully deployed. Trial patients will be those who have a high or extreme surgical risk for open-heart surgery.
The product is CE Mark-designated in Europe but investigational in the U.S.
The FDA approves the Entovis pacemaker system with ProMRI technology made by Berlin, Germany's Biotronik. The device allows patients to undergo MRI scans with a limited exclusion zone. Entovis patients need only to alert radiology staff and they will verify that they are eligible to undergo the imaging. The company believes that this is a significant advantage over MRI-conditional pacers. The FDA's approval covers both single and dual chamber pacemakers when implanted with Setrox leads.
Recent research finds that there is a 50 - 75% probability that patients implanted with a pacemaker or defibrillator will need an MRI at some point in their lives.
St. Jude Medical, Inc., develops, manufactures and distributes cardiovascular medical devices for global cardiac rhythm management, cardiovascular, atrial fibrillation therapy areas and neurostimulation medical devices for the management of chronic pain.