Stryker's iVAS kyphoplasty system: Firm's Interventional Spine business launches iVAS minimally invasive, vertebral augmentation system for use in treating vertebral compression fractures (VCFs), Stryker announces April 13. During vertebral augmentation, also known as balloon kyphoplasty, a balloon catheter creates a void in the collapsed vertebra into which bone cement is delivered, creating an internal cast that stabilizes the fracture and alleviates pain in about 90% of patients, Stryker says. According to the firm, about 700,000 VCFs occur per year. Stryker now offers balloon kyphoplasty and vertebroplasty solutions on the same portfolio of "mixer and delivery systems, bone cements and needles," the firm notes, "giving physicians the flexibility to customize their treatment approach based on the type of compression fracture and patient anatomy." One recent study, however, suggests vertebroplasty treatment of spine fractures may have no lasting benefit (1"The Gray Sheet" Aug. 10. 2009)
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
