Regulatory

Sanofi’s breakthrough device talks anaphylaxis patients and caregivers through the injection process at what is likely to be a particularly stressful time.

UNomedical’s neria infusion sets are the subject of a Medical Device Alert in UK as a result of the identified risk of needle breakage with the consequent need for needle removal.

Stryker Neurovascular’s Trevo® Pro Retriever has gained FDA 510(k) market clearance. The Trevo® Pro Retriever outperformed Stryker’s own Merci® Retriever in a clinical study first published in May, showing improved revascularisation compared with the older generation product.

J&J subsidiary business Ethicon Endosurgery has issued a voluntary recall of certain lots of its PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories. The recall was provoked by reports of difficulty firing the device although the company seems to have no problem doing so when reloading returned devices.

News and views from the medtech industry, chewed over and spat out by our resident polemicist when he’s not involved in the Olympics (in a strictly observational capacity you understand)

Florida based autologous solutions company Biologic Therapies has gained FDA clearance for its Bio-MAC™ Bone Marrow Aspiration Catheter which it claims will enhance physicians’ use of autologous Bone Marrow Aspirate Concentrate in surgical procedures for the treatment of orthopedic conditions.

Ethicon Endo-Surgery, Inc. has announced U.S. FDA 510(k) clearance of its HARMONIC ACE®+ Shears with Adaptive Tissue Technology. The company says this represents the next generation in its “best-in-class” HARMONIC® portfolio of ultrasonic surgical devices that can handle multiple surgical jobs.

The consequences of our distinct regulatory set-ups is that sometimes study information that drives indications for use one side of the pond is ignored on the other, despite the fact that it may have significant clinical consequences as seems to be the case with Stryker’s Wingspan Neurovascular Stent.

Codman has announced receipt of U.S FDA approval through a PMA supplement for its MEDSTREAM™ Programmable Infusion System. MEDSTREAM is an implantable infusion pump and catheter system used in the treatment of spasticity, a movement disorder often caused by stroke, cerebral palsy, multiple sclerosis or spinal cord injury.

Abbott has announced U.S FDA approval for its Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease. The stent, already CE marked and marketed in Europe, has passed muster with the FDA following a comparative multicentre clinical study which suggested it outperforms endpoints established from previous stent studies..

Eye health company Bausch + Lomb, and Technolas ™ Perfect Vision GmbH , a leading ophthalmology laser company, have jointly announced that the VICTUS™ Femtosecond Laser Platform has received FDA 510(k) clearance. The VICTUS platform is the first femtosecond laser capable of supporting cataract and corneal procedures on a single platform.

NeuroMetrix, Inc., a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, announced that it has received 510(k) clearance for its SENSUS™ Pain Management device from the U.S FDA.

A “Talking” Blood Glucose Meter that doesn’t talk. A sterile urinary catheter that isn’t sterile. A reprocessing unit that risks contaminating its contents. A week in the life of UK MHRA’s safety/recalls/alerts department.

Sunshine Heart tells us it’s come up with a device upgrade which will make its CPulse heart assist device run quieter and less bulky. The company awaits the FDA’s formal confirmation that it’s good to go, but the conditional approval has been announced. And the share price has gone up.

Covidien has confirmed that it notified customers on July 18, 2012, about a voluntary global recall of certain lots of its Shiley™ reusable cannula, cuffed adult tracheostomy tubes, size 8. This action was in response to reports of volume leakage and/or disconnection between the inner and outer cannulae.

DePuy Synthes Spine has received FDA 510(k) clearance for use of its EXPEDIUM®(pictured), VIPER®, and VIPER®2 Spine Systems on patients with adolescent idiopathic scoliosis (AIS), expanding the scoliosis indication for the pedicle screw systems, previously only approved in adults.