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Critical Vertebroplasty Studies Raise Questions

Executive Summary

The lines separating politics and the medical device industry have long been erased as industry, regulators and insurers wrangle over critical issues like innovation, product approval and compensation for medical care. But the New England Journal of Medicine tossed itself into the tangle last month by publishing two clinical trials that called into question the efficacy of vertebroplasty, the increasingly common procedure that involves the percutaneous injection of bone cement in the core of a fractured vertebra.

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DFINE Seeks Meaning Outside Of Spine

Privately held DFINE Inc., a supplier of tools for treating vertebral compression fractures in the spine, is trying to reposition itself from being a spine company to an “interventionalist company” that provides tools necessary to interventional radiologists, neuroradiologists, and oncologists.

Vertebral Compression Fracture Treatments Under Pressure

A decade ago, the treatment of vertebral compression fractures (VCF) represented one of the fastest - and most innovative - segments of a spine industry that was set to explode. The two principal procedures - vertebroplasty and its distant cousin kyphoplasty - presented surgeons and interventionalists with a minimally invasive option to stop pain and, in the case of kyphoplasty, restore the shape and form to a broken vertebra. Now, two studies published in The New England Journal of Medicine suggesting that vertebroplasty procedures were no more effective in relieving pain than a placebo treatment have put pressure on VCF companies and doctors, who are facing pushback on reimbursement and some skepticism from even their own specialists.

Vertebral Compression Fracture Treatments Under Pressure

A decade ago, the treatment of vertebral compression fractures (VCF) represented one of the fastest - and most innovative - segments of a spine industry that was set to explode. The two principal procedures - vertebroplasty and its distant cousin kyphoplasty - presented surgeons and interventionalists with a minimally invasive option to stop pain and, in the case of kyphoplasty, restore the shape and form to a broken vertebra. Now, two studies published in The New England Journal of Medicine suggesting that vertebroplasty procedures were no more effective in relieving pain than a placebo treatment have put pressure on VCF companies and doctors, who are facing pushback on reimbursement and some skepticism from even their own specialists.

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