Spine Firms Make Last-Ditch Appeals For CMS Support Of Percutaneous Lumbar Decompression

Two medical device makers that stand to lose under CMS’ proposed noncoverage of percutaneous image-guided lumbar decompression say the agency’s proposal would unwisely eliminate a promising alternative to invasive surgery for the treatment of lumbar spinal stenosis. One suggests coverage with evidence development to allow more data collection, an approach also advocated by the North American Spine Society.

Vertos Medical Inc. and VertiFlex Inc., two medical device makers that stand to lose under CMS’ proposed noncoverage of percutaneous image-guided lumbar decompression, argue that the proposal would unwisely eliminate a promising alternative to invasive surgery for the treatment of lumbar spinal stenosis.

Their comments, and 195 others, were submitted in response to CMS’ Oct. 17 proposed decision that the minimally invasive procedure is not reasonable and necessary for treating lumbar spinal stenosis...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Policy & Regulation

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Industry Execs Talk Tariff Turbulence During MD&M East

 

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

Pathogen Sharing System Part Of Global Pandemic Agreement

 

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

More from Medtech Insight

Bone Surgery Startup Surgify Medical Raises $7.9m

 

Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

German Bionic Launches ‘Strongest Exoskeleton To Date’

 

German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.