Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

FDA Clears the Provant Therapy System for Use by Patients with Metallic Implants

January 6, 2014 By PR Newswire

Clinicians can now treat the post-operative pain from joint replacements and spinal fusions

Regenesis Biomedical, Inc., today announced that FDA has approved the removal of the contraindication for use of the Company’s Provant Therapy System in patients with metallic implants in the area of treatment. The decision was made after the FDA reviewed additional data and research demonstrating that the use of Provant’s Pulsed Electromagnetic Therapy (PEMT) did not put such patients at risk.

“The positive effects of using our non-thermal PEMT Therapy to treat patients with persistent post operative pain have been reported by both doctors and patients,” commented Scott S. Brooks, President and Chief Executive Officer of Regenesis Biomedical. “The FDA’s decision to approve the removal of this contraindication for the Provant System allows many more patients to benefit from Provant Therapy.”

Mr. Brooks continued, “The clinical literature reports a significant unmet need for effective pain therapies in patients undergoing orthopedic surgery. A recent case series shows Provant Therapy may be beneficial for treating Failed Back Surgery Syndrome (FBSS) patients as a means to avoid more invasive and expensive therapies. This decision by the FDA expands the number of patients who might benefit from Provant Therapy. We are now actively engaging orthopedic, podiatric, primary care, and rehabilitation clinicians to educate them on the benefits of Provant Therapy for resolution of postoperative pain. Provant is a non-narcotic, non-invasive and safe option for patients in need.”

Each year about 1.1 million patients have hip, knee, shoulder and elbow replacements, 350,000 have a spinal fusion, and 600,000 require metal implants. Substantial pain following surgery is prevalent; for example, 32% of knee replacement patients experience ongoing pain. Common metal implant procedures that result in post-operative pain include knee and hip replacements, spinal fusion, and bone fracture internal fixation.

Related Articles Read More >

Johnson & Johnson Office of Digital Innovation Leader Peter Schulam
Imagining the future of cloud-connected medical devices with Johnson & Johnson leaders
Withings Body Scan
Withings plans launch for Body Scan smart scale platform
BinaxNow COVID-19 Ag Card
Time recognizes Abbott offerings among this year’s 100 best inventions
Koya Medical’s Dayspring device
Koya Medical reports positive early results in Dayspring lymphedema trial

DeviceTalks Weekly.

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech