Regulatory

Heart assist device company Thoratec Corporation has initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II® LVAS Pocket System Controller. The advisory follows four deaths among patients while initiating switches of controller.

Frequent visitor to our pages, cardiovascular device company Biotronik has announced the first implantations of the Sentus ProMRI® lead.

Eucomed’s Chief Executive, Serge Bernasconi is making sure medtech industry’s voice is being heard right until the last minute as final wording is being inked into the new medical device directives. Highlights from his newly issued blog included here.

InTone® MV is a clever device which combines muscle stimulation with voice-guided pelvic floor exercise, visual biofeedback, and a unique, customizable probe to create a home-based treatment for fecal and urinary incontinence in men and women.

New entrant into the orthopaedic device space, EDGE Orthopaedics has its first FDA 510(k) Clearance in the form of a range of compression screws.

Clever idea this. The FDA has just cleared a system known as KASM from Ortho Developments Corporation. These spacer molds are intended for use after removal of primary TKA implants following infection and offer a degree of articulation to the patient.

Covidien plc has announced its Puritan Bennett™ 980 ventilator has received U.S. FDA 510(k) clearance. The company says its new acute care ventilator is designed to be simple, safe and smart and to enable patients to breathe more naturally than with conventional mechanical ventilators.

Cardica, Inc. is a relative minnow in the world of minimally invasive surgical stapling devices. Now however it has announced two significant new FDA clearances that may well help it to compete with its rather bigger adversaries.

Integra LifeSciences Holdings Corporation has announced the FDA 510(k) clearance and commercial introduction of the Integra® Titanium Bone Wedges, designed for internal fixation for bone fractures or osteotomies in the foot and ankle.

Surgical patients can suffer nerve impairment due to so-called “positioning effect”. Now SafeOp Surgical’s newly FDA cleared system uses neurological monitoring to flag up potential peripheral nerve damage.

Paragonix Inc has big ideas about extending transit and storage time for donor hearts. For now though it’s satisfied with a new FDA clearance that sees its Sherpa Pak system good to enter the market for use within current guidelines.

Contact force-sensing has become something of a buzz word in cardiac ablation as the benefits of being able to avoid too much or too little contact become apparent. Now Biosense Webster has become the first to get its contact force sensing catheter FDA approved.

Orthobiologics company BioStructures, LLC, has seen its Signafuse™ Bioactive Bone Graft Putty granted U.S.FDA 510(k) clearance. Signafuse™ is indicated for the posterolateral spine, extremities and pelvis as well as a bone graft extender in the posterolateral spine.

Last year it gained CE mark approval for it’s MIS non-pedicle screw spinal fusion system. Now Aurora Spine has gained Australia’s green light in the form of a TGA clearance to market the device.

It’s been pretty quite in Renal Denervation territory since the January bombshell of Symplicity HTN-3 clinical outcomes. Nonetheless, one company, Cordis, has pushed ahead with its CE marking and now been granted its EU approval.

Cyberonics, Inc. has gained CE Mark approval for its AspireSR generator, the novel sixth-generation Vagus Nerve Stimulation (VNS) Therapy generator.