AtriCure (West Chester, Ohio), a developer of technologies for the surgical treatment of atrial fibrillation(Afib) and left atrial appendage management, said the first two patients have been enrolled and treated at PinnacleHealth CardioVascular Institute (Harrisburg, Pennsylvania), in the Dual Epicardial and Endocardial Procedure (DEEP) clinical study.
A peripheral vascular intervention indication could quite possibly put Corindus Vascular Robotics and its CorPath System on a very different playing field and open up a larger and more robust market for the firm.
Medtronic (Dublin) reported the launch of the Euphora Semicompliant Balloon Dilatation Catheter in countries that recognize the CE mark. The first patient case with the Euphora Semicompliant Balloon Catheter was recently performed by Richard Edwards, consultant cardiologist at the Freeman Hospital in Newcastle, UK.
Medtronic (Dublin) said that it has received clearance from the FDA for expanded indications of the Vertex Reconstruction System. The new clearance for the Vertex family of products allows for lateral mass and pedicle screws to be used as a form of fixation to treat various pathologies occurring in the posterior cervical spine, making it one of the first FDA-cleared systems available in the U.S. for use of screws at C1-C7.
Sequent Medical (Aliso Viejo, California) said that the FDA has approved the inclusion of the SL ("Single Layer") family of WEB Aneurysm Embolization Device devices for use in its U.S. Investigational Device Exemption clinical study called WEB-IT. The firm originally gained FDA approval to go ahead with the trial in August of last year.