The FDA has sent letters to physicians declaring a Class 1 recall of the Sutureless Connector intrathecal catheter made by Medtronic Inc. The device might be incorrectly labeled as compatible with the IsoMed Pump Model 8472, a drug pump Medtronic discontinued last year as part of what it calls a “planned product phase-out.” The catheter models 8709SC, 8731SC, 8578, and 8596SC are affected by the recall. Even though the catheter appears to fit the pump, the connection is not secure, which can cause drugs or cerebrospinal fluid to leak out, resulting in drug overdose, tissue damage and so-called spinal headaches.

The advisory panel for the FDA has backed a new type of heart valve that can be implanted without the open heart surgery required for traditional valves. Medtronic Inc’s Melody heart valve has been recommended for approval for the group of people born with cardiac defects that impede blood flow from the right ventricle to the pulmonary artery. The device can be implanted by threading a tube through a leg vein to the heart.

Panel recommends Melody Transcatheter Pulmonary Valve
The FDA’s Circulatory System Devices Panel has unanimously recommended the approval of Humanitarian Device Exemption of Medtronic’s Melody Transcatheter Pulmonary Valve. The device is designed for patients with congenital heart defects, status post open heart surgery, who developed right ventricular outflow tract (RVOT) obstruction. The Melody Transcatheter Pulmonary Valve is the first transcatheter heart valve to be approved for commercial use anywhere in the world and the first to be reviewed by an FDA panel.

Medtronic, Inc. has announced the U.S. market launch of the Sprinter Legend (semicompliant) and the NC Sprinter (noncompliant) balloon dilatation catheters on a rapid exchange delivery system. Recently approved by the U.S. Food and Drug Administration, the Sprinter Legend balloon catheter provides the latest innovations in balloon technology and is equipped to address difficult lesions in coronary angioplasty procedures. The Sprinter Legend balloon catheter features the lowest pre-dilatation profiles, making it suitable for use in challenging lesions, as well as allowing for the use of two balloons simultaneously in a small, guide catheter.

Cook Medical has received the CE Mark approval for its MiraFlex™ High Flow Microcatheter. Designed to complement the company’s existing embolisation products and coils, the device represents the newest improvement in micro-catheter technology. It enhances traceability necessary to access the most distal vasculature. Having an inner diameter of .025 inch, the catheter is approved for use in small vessels. It enables coil delivery in the finest way.

The U.S. Food and Drug Administration has approved Endologix, Inc.’s IntuiTrak™ Delivery System. The novel system will facilitate minimally invasive delivery. It will help  deploy the Powerlink stent graft [indicated for endovascular repair of AAA abdominal aortic aneurysms (AAA)]. The device has improved flexibility. It features advanced hemostasis control. An integrated sheath introduces ancillary devices during AAA procedure, reducing blood loss and the procedure time.

Cook Medical has launched its  Advance® 18LP Balloon Dilatation Catheter in North America. Designed to provide improved deliverability to doctors, Advance 18LP has small sheath compatibility and a low crossing profile. The .018″ wireguide PTA balloon can be used in patients having lesions of the peripheral arteries as well as obstructive lesions of native or synthetic arterio-venous dialysis fistulae. It uses advanced thermal setting of the balloon folds for better rewrap and sheath pull-back. Lower deflation time is its another benefit.

The U.S. Food and Drug Administration has cleared Lumen Biomedical, Inc.’s LBI Embolectomy System to remove fresh, soft embolus and thrombus from vessels in the peripheral vasculature. The device consists of a 0.014″ guide wire that consists of a 3D fiber-based element used along with the Xtract Aspiration Catheter that had been cleared previously. It is based on the same technology that drives Lumen’s embolic protection system. The system will be helpful in the treatment of Peripheral Arterial Disease.

The U.S. Food and Drug Administration has given the 510(k) clearance Interrad Medical, Inc.’s SecurAcath(TM) PICC with Subcutaneous Securement System. The novel method for catheter securement uses a small anchor which is deployed in the subcutaneous tissue just under the skin to hold an indwelling catheter firmly in place. The catheters, currently in use, are secured on the surface of the skin of the patient using adhesive devices. The SecurAcath system also reduces the time for catheter maintenance, bringing down the costs related to it. The risk of infection related to catheter is also lowered by improved cleaning of exit site and minimizing the motion.

OrbusNeich’s Sapphire(TM) 1.25mm PTCA dilatation catheter has received the CE Mark approval, a company announcement says. The product is slated for immediate roll-out. It affords greater pushability and superior kink resistance to the physicians. According to Professor Tan Huay Cheem of the University Hospital in Singapore, the product may be considered to be a first choice for the treatment of highly stenotic lesions.