Cardio

Stereotaxis, Inc. has been granted FDA 510(k) clearance to market its Vdrive™ Robotic Navigation System with V-Sono™ Intracardiac Echocardiography (ICE) … continue reading “FDA Clears Stereotaxis Robotic Navigation and Intracardiac Echocardio Catheter Manipulator”

“From our experience over the last two years, the MGuard Prime EPS has improved patient outcome and led to brilliant … continue reading “First Patient in MGuard™ Prime Embolic Protection Stent Trial”

SynCardia Systems, Inc. has announced that 100 implants of the its temporary Total Artificial Heart have been performed in 2013. This milestone was achieved three months earlier than in 2012, when the 100th implant was performed on Oct. 16.

ValveXchange®, Inc., says it is moving a step closer to market, having submitted its application for CE mark approval. The … continue reading “Novel Serviceable Heart Valve May Offer Potential of Transcatheter Re-do’s”

St. Jude Medical, Inc. has reported sales and net earnings for the second quarter ended June 29, 2013. Background We … continue reading “Mixed Bag for St.Jude Medical Sees Cardiac Rhythm Business Propped Up by The Rest”

Australia’s regulatory authority, the Therapeutic Goods Administration (TGA) has issued a hazard alert pertaining to one of Medtronic’s pacing devices, the Consulta Cardiac Resynchronization Therapy Pacemaker (CRT-P). The action coincides with the company’s recall of certain Consulta and Syncra CRT-P devices.

Italy’s Sorin Group has issued a press release in which it confirms it will be participating in the manufacture of … continue reading “Sorin and Boston Scientific in TAVI Manufacturing Tie-up”

Boston Scientific Corporation has received U.S. FDA 510(k) clearance and CE Mark approval for the Guidezilla™ Guide Extension Catheter and … continue reading “FDA/CE Nod And Launch For Boston Sci’s Guidezilla™ Guide Extension Catheter”

Medtronic has issued a press release relating to a the ruling by a court in Mannheim Germany that its CoreValve® Transcatheter Valve System infringes a patent owned by Edwards Lifesciences. Suffice it to say they’re not happy.

Stentys, developer of the world’s first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), has received approval to … continue reading “Stentys Self-Apposing Stent Gets Broader Coronary Indications”

CryoLife, Inc.has announced that it has received U.S. FDA premarket approval for its new Sologrip® minimally invasive laser fiber-optic delivery system, a single-use, disposable handset designed for use with the Company’s Cardiogenesis transmyocardial revascularization system.

Abbott has announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the XIENCE Xpedition™ Everolimus Eluting Coronary … continue reading “Japanese Approval For Abbott’s XIENCE Xpedition™ Drug Eluting Stent”

Tyrx Inc’s, Inc. fully Resorbable AIGISRx® R Antibacterial Envelope for use with pacemakers and implantable cardioverter defibrillators has gained U.S. FDA clearance.

Last month we covered the EU launch of Boston Scientific’s respiration-sensitive Vitalio™ pacemaker. Now the company has announced the first post-launch implantation of the device, which has taken place at a Dutch hospital.

In a statement on its website, European medtech industry body Eucomed, has welcomed the news that Eusopean Society of Cardiology (ESC) Guidelines support Cardiac Pacing and Cardiac Resynchronization Therapy (CRT), finding it useful and effective, based on solid clinical evidence.

Dallen Medical, an emerging medical device company, has announced that the first three patients have been treated using its proprietary Compressyn™ Band sternal closure device.