Medtronic, Inc. Get Approval from United States Food and Drug Administration for the Launch of DF4 High-Voltage Connector System
January 30, 2012 at 02:00 pm
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Medtronic, Inc. announced the United States Food and Drug Administration (FDA) approval and launch of the DF4 High-Voltage Connector System, a right ventricular lead and connector used with implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) to detect and accurately treat potentially life-threatening heart rhythms. The DF4 Connector System helps simplify implantation procedures via a redesigned port and provides additional reliability by giving physicians visual confirmation of the lead connection to the device. The DF4 connector uses the same lead body as Medtronic's Sprint Quattro(R) lead, which has more than a decade of proven performance and a high safety and efficacy profile. The DF4 design includes fewer connections between the device and the defibrillation leads. Prior to the development of the DF4, traditional high-voltage connector systems required up to three connections. The DF4 connector has a single set-screw to connect the lead to the device and is available on several Medtronic ICDs and CRT-Ds, including the Protecta(R), Consulta(R) and Secura(R) portfolio of implantable defibrillators. In addition to the U.S., the DF4 High-Voltage Connector System is approved for use and available in most geographies including Europe, Japan, Canada, and Australia.
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).
MEDTRONIC PLC 
