Products

CIVCO Medical Solutions has gained FDA clearance of its Protura™ Robotic Patient Positioning System integration with Varian Medical Systems’ Motion Management Interface. The system delivers accurate patient positioning, one of the most important issues in radiation oncology

Advanced Catheter Therapies, Inc. has gained FDA clearance for its clever multi-lumen Occlusion Perfusion Catheter™. The device enables the operating physician to occlude and isolate a section of vessel and deliver a therapeutic agent in a controlled and effective manner.

The U.S. FDA’s Circulatory Systems Devices Advisory Panel has narrowly voted (4 vs 3 with one abstention) that biventricular (BiV) pacing with Medtronic, Inc. devices is beneficial for treating patients who have atrioventricular (AV) block and left ventricular (LV) systolic dysfunction, compared to conventional right ventricular pacing.

A customer complaint investigation uncovered a potential problem with Edwards Lifesciences’ EMBOL-X Glide Protection System. It seems incidences of a bent tip may present a risk of breakage and subsequent embolization, so in the UK at least the company has issued a recall notice for certain batches.

Binder Biomedical Inc. has announced that its new LOGIC intervertebral body fusion device has been cleared by the FDA. The complete anterior lumbar fixation system will see its initial launch early next year.

Terumo describes its newly launched Azur CX as the first and only Peripheral Coil designed for cross-sectional coverage incorporating the benefits of Terumo® patented hydrogel technology. The hydrogel confers flexibility and swells to stabilise the coil in the vessel.

Zilico Ltd has gained CE Mark certification for its cervical cancer diagnostics device, ZedScan™ I. The UK company’s ground-breaking system offers quick, accurate detection of cervical neoplasia in real-time, enabling clinicians to improve patient management.

OrthoSensor™ has announced plans to launch its Verasense™ Knee System in European markets after recently receiving CE Mark approval. Verasense is the first integrated intelligent orthopaedic device to provide surgeons with real-time quantitative data on knee implant positioning, limb alignment and soft tissue balance during total knee replacement surgery.

Medtronic, Inc., a world leading spinal technology company, has taken the opportunity presented by two big spinal congresses to announce the CE marking and European launch of a new cervical cage system which expands the successful Compact CORNERSTONE-SR® platform of cages.

A.M. Surgical, Inc. has announced the launch of the Stratos™ Endoscopic Carpal Tunnel Release System. The Stratos™ offers a minimally invasive surgical approach to relieve the symptoms of carpal tunnel syndrome and results in a smaller incision, less pain and a quicker return to work and normal activities when compared to traditional open carpal tunnel release surgery.

Californian spinal technology company DFINE, Inc., has now received CE Mark approval for its STAR™ Tumor Ablation System for treatment of painful metastatic spinal tumors. The company officially launched the system in Europe at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress last month.

Heart rhythm and home monitoring specialist Biotronik, has gained FDA approval for its Ilesto family of implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillators (ICD/CRT-D) devices.

Baxano Surgical, Inc. has announced the launch of a novel disposable facetectomy instrument called iO-Tome that it says allows surgeons to perform rapid and safe facetectomies when performing certain interbody spinal fusion procedures.

Surgical implant company RTI Surgical Inc. has seen a first implantation of the company’s map3™ Cellular Allogeneic Bone Graft implant in a foot and ankle procedure. The case was complex, the immuno-compromised patient demanding a graft that would heal.

Cochlear Limited has announced the commercial launch of its Nucleus® 6 Sound Processor in the United States. The company says recipients of its new implant will benefit from a wide range of new design features that are easy to use and designed to fit each person’s lifestyle.

Medtech industry is focused on the significant matter of the punitive and unfair sales tax. Companies would do well to stop taking EU market access for granted though, as new rules will slow things down and increase costs to beyond FDA levels. This is serious.