The U.S. Securities & Exchange Commission today accused former Sientra (NSDQ:SIEN) CEO Hani Zeini of hiding a problem at the company to close a $61 million follow-on offering that led to the company losing more than half of its value. The breast implant maker relied on a single supplier for its silicone implants. But regulators in […]
MedAutonomic implants device to treat metabolic syndrome
MedAutonomic said today it has successfully implanted a brain neuromodulation device, the Phoenix, into the stomach wall of a human through an innovative digestive endoscopic procedure. Powered without a battery, the Phoenix sends signals to the limbic system to reset an imbalance in the autonomic nervous system to treat metabolic syndrome and functional diseases […]
Zavation, PanMed join forces in spinal device market
Spinal hardware and biologics company Zavation Medical Products (Jackson, Miss.) said today that it has partnered with the management team of Pan Medical U.S. Corp. to buy that company. PanMed (Tampa, Fla.) designs, develops and manufactures highly complex medical products including balloons, catheters, needles, and instrument kits used in minimally invasive procedures, primarily in kyphoplasty and interventional radiology. […]
Gore’s aneurysm device for tricky anatomies implanted in Europe
The first European patient with a challenging anatomy has had the Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis implanted, according to W.L. Gore & Associates. The next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms in patients with difficult anatomies. They include patients with proximal aortic neck angles […]
Paradigm Spine wins coverage for spinal stenosis implant
BlueCross BlueShield of South Carolina has extended coverage to Paradigm Spine’s Coflex interlaminar stabilization implant, the company announced today. Approved by the FDA in 2012, Coflex is a non-fusion, motion-preserving stabilization implant for the treatment of lumbar spinal stenosis (LSS). Used in conjunction with a decompression procedure or in lieu of a spinal fusion, Coflex is a single-piece, […]
Longeviti’s ClearFit gives neurosurgeons a view inside the head
Longeviti Neuro Solutions has launched its novel ClearFit implant to correct and/or restore bony voids or defects of the cranium. This clear, patient-specific implant enables neurosurgeons to see neuroanatomy and critical functional components beneath the ClearFit once it is implanted. “The real advantage to this system is the ability to see what’s underneath the […]
MicroPort’s drug-eluting stent performs well in European study
MicroPort Scientific’s Firehawk rapamycin target eluting coronary stent performed comparably to Abbott’s Xience stent family in a study just published in The Lancet. The TARGET AC multi-center, randomized controlled trial enrolled 1,653 patients at 21 clinical study sites in Europe. Firehawk met the trial’s non-inferiority primary endpoint of target lesion failure rate at 12 months of 6.1% versus 5.9% for the […]
Certain polyethylene-lined hips may last longer than others
Researchers in New Zealand found that artificial hip liners made of highly-cross-linked polyethylene showed less wear 10 years after implantation than liners made of conventional ultra-high-molecular-weight polyethylene. Patients whose hip liners were made of highly cross-linked polyethylene also had a significantly lower prevalence of osteolysis and revision surgery, according to a report in Orthopedics Today. That’s because cross-linking […]
BlueWind posts positive follow-up study results
Neurostim developer BlueWind Medical reported positive results from a follow-up study of patients using its implantable tibial nerve stimulator for overactive bladder (OAB). Renova iStim is a leadless, miniature, wireless neurostimulation platform designed for the treatment of multiple clinical indications. Three years after implantation of the BlueWind’s Renova iStim device, 75% of patients experienced at least a 50% […]
Pixium Vision’s novel Prima chip helps patients see the light
Pixium Vision said today that its Prima miniature wireless photovoltaic sub-retinal implant has been activated in the first five patients. The patients all have severe vision loss from atrophic dry age-related macular degeneration. They are enrolled in a three-year clinical study in France to evaluate the safety and function of the Prima chip in eliciting visual […]
FDA gives nod to Eden Spine’s Sphynx
Eden Spine’s Sphynx plating system has won FDA clearance, the company said today. Sphynx was designed to complement the company’s Giza titanium vertebral body replacement with rotatable endplates, introduced in 2012. The Giza is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or a fracture and provides multiple […]
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