Provant also reduces pain by inducing endogenous opioids. On January 9, 2012, Regenesis Biomedical, Inc., a medical technology company that markets the Provant ® Therapy System, announced that William (Bill) Gittinger joined the company as Vice President of Reimbursement and Health Economics. The FDA removed the metal-implant contraindication for the Provant Therapy System, making Provant available for use in patients with metallic joint-replacement components and internal-fixation devices.Provant uses pulsed radio-frequency (RF) waves to treat postoperative pain and edema in superficial soft tissue. The results indicate that when compared to a … Provant Therapy treats your pain site using pulsed electromagnetic energy; it is an energy field set to specific parameters, shown to reduce pain and inflammation. The Provant Therapy System is currently FDA-cleared for the treatment of postoperative pain and edema of soft tissue, and is used throughout the Veterans Affairs system as a safe, non-drug alternative to prescription opioids. Provant Therapy treats your pain site using pulsed electromagnetic energy; it is an energy field set to specific parameters, shown to reduce pain and inflammation. Provant treatments are twice a day, 30 minutes morning and 30 minutes evening. User and Regenesis agree that User shall have no right to transfer or assign any Provant, to anyone, and that upon discontinuance of prescription or other rental term that Provant will be returned to Regenesis as requested by Regenesis. The Provant treatment pad is placed against your treatment area. Regenesis is a medical technology company focused on developing and marketing regenerative medicine products. The Provant Therapy System is available by prescription only. Arizona medical device maker Regenesis Biomedical won new labeling for its Provant Therapy system, removing a contraindication discouraging doctors from using the system … Its customers include acute care hospitals, long-term acute care hospitals, skilled nursing facilities and … scientists who became very interested in the potential for pulsed electromagnetic field energy. Safe, Non-Drug Pain Management. About the Provant ® Therapy System. This field is for validation purposes and should be left unchanged. Pain medications may cause drowsiness, nausea, constipation, sleeplessness, dizziness, vomiting, abdominal discomfort, itching, mood changes, and difficult urination. Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Opioid-related complications may increase the need for healthcare. The request for a Provant therapy system twice daily for 60 days was denied by utilization review on 08/07/13. The optimized therapy emitted from the treatment pad creates a dome-shaped therapy field in the area that you are treating. Regenesis continues to invest in expanding the team and building the body of clinical evidence for the Provant Therapy System Scottsdale, Arizona, January 23, 2012 — Regenesis Biomedical, Inc., a medical technology company that markets the Provant® Therapy System, announced today Gregory Shipp, MD, joined the company as Director of Clinical Research. Provant Therapy is delivered to your patient’s home. The therapeutic field is typically sensation-free. The Provant Therapy System is an electromagnetic medical device intended as an adjunctive treatment for post-operative pain and edema in superficial soft tissue. Provant relieves pain two ways: through anti-nociceptive analgesia by inducing endogenous opioids, and by regulating inflammatory mediators. Regenesis’ customers include health care facilities and providers that serve patients treated in hospitals, rehabilitation centers, outpatient clinics, and by patients self-treating at home. Surgical procedures may result in pain; opioids are often prescribed to help. By helping the body produce more naturally-occurring anti-pain compounds. Subject has previously treated with PROVANT® Therapy System within 60 days on the lower extremity. As it helps relieve pain, Provant may reduce your patient’s need for analgesic drugs, including narcotics. Subject is unwilling or unable to follow study instructions or comply with the treatment regimen, diary documentation, and study visits. In one study, the Provant Wound Closure System was specifically evaluated. A Patient Care Coordinator will call the patient; they will make sure the patient knows how to use the device, and have the supplies they need. An Open-Label Trial of PEMF Therapy [Provant Infinity Therapy System] for Home Use in Postoperative Pain. Provant also reduces pain by inducing endogenous opioids. Cutaneous wounds normally heal in predictable stages: hemostasis and inflammation, granulation, epithelialization, maturation and remodeling. The company was founded back in 1997 by two N.I.H. This video shows how the Provant Therapy System works to reduce inflamation and pain. Regenesis has Patient Care Coordinators who will be in touch with you to help with your use of Provant Therapy. Located in Scottsdale, Arizona, Regenesis has developed, patented, and now makes the Provant® Therapy System. Provant does this by exposing the tissue to electromagnetic energy, using an optimized energy pulse. In this new role, Bill is chartered with securing expanded payor sources for the Provant Therapy System. Provant reduces pain by inducing the natural endogenous opioids that form in the body to reduce pain. Subject has pain from any other source that can confuse the assessment of the pain associated with DPN. Provant Therapy may reduce pain medication usage. Outcome Measures. You treat with Provant twice a day (30 minutes morning and 30 minutes evening). Provant may decrease the pain and swelling associated with surgery and debridement, helping tissue move through, and out of, inflammation. Illustration of the InvisibleDome-Shaped Therapy Field Other Name: Radio frequency generator devices. Provant is a safe and effective medical device that is adjunctive and noninvasive. The Provant Therapy System is a non-invasive device that creates an electromagnetic field to reduce pain, swelling, and edema after surgery by controlling inflammation and creating endogenous opioids. Scottsdale, Arizona, December 13, 2013 — 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. Provant is a medical device that decreases the pain and swelling associated with operative procedures, helping tissue move through, and out of, inflammation. As it helps relieve pain, Provant may reduce your patient’s need for analgesic drugs, including narcotics. (2003) published the results of a randomized trial involving 49 patients with pressure ulcers who received standard wound therapy combined with the Provant Wound Closure System. About the Provant® Therapy System Provant uses pulsed radio frequency energy (PRFE) to facilitate reduction of the pain and edema associated with post-operative, superficial soft tissues. Per the report, the patient was felt to have not have improved significantly with therapy to warrant additional physical therapy. Provant Therapy System throughout the rental period. Device: Provant Therapy System: Not Applicable: Detailed Description: The study is multi-site, randomized, double-blind, sham-controlled study of the safety and efficacy of multi-dose Provant therapy to evaluate neuronal and vascular response in the treatment of subjects with painful peripheral diabetic neuropathy. The optimized therapy emitted from the treatment pad creates a dome-shaped therapy field in the area that you are treating. Provant may … Listing a study does not mean … Provant is a medical device that decreases the pain and swelling associated with operative procedures, helping tissue move through, and out of, inflammation. Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria … If you receive VA healthcare you can now request Provant therapy. This field is for validation purposes and should be left unchanged. The Provant Wound Therapy System is a safe adjuvant non-invasive medical device. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Regenesis warrants that the Provant Therapy System and About the Provant® Therapy System Provant uses pulsed radio frequency energy (PRFE) to facilitate reduction of the pain and edema associated with post-operative, superficial soft tissues. Provant is a safe, non-drug medical device delivered to your home. Regenesis offers the Provant® Therapy System, an FDA-cleared medical device that is a safe, prescriptive non-drug alternative to opioids. Provant is indicated for adjunctive use in the palliative treatment of post-operative pain and edema of soft tissue. The Provant Therapy System has treated over 5,000 patients, and, through new clinical trials, we hope to enable further access to patients in need." SCOTTSDALE, Ariz., Jan. 9, 2012 /PRNewswire/ -- Regenesis Biomedical, Inc., a medical technology company that markets the Provant® Therapy System, announced today William (Bill) Gittinger joined the company as Vice President of Reimbursement and Health Economics. In this new role, Bill is chartered with securing expanded payor sources for the Provant Therapy System. Clinicians can now treat the post-operative pain from joint replacements and spinal fusions. Illustration of the Invisible Ritz et al. Regenesis developed, patented, and now markets the Provant Therapy System. The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device. The system includes a durable device and disposable applicator covers. Learn More By resolving the pain-causing swelling and inflammation. The Provant Therapy System is a non-invasive medical device that delivers dual-field pulsed electromagnetic energy to an area of pain for a therapeutic and drug-free solution. About the Provant Therapy System . In general, if an acute wound fails to heal within four to six weeks, it should be considered chron… Provant ® Therapy System. The Provant Therapy System treats pain using electromagnetic energy. Regenesis offers the Provant® Therapy System, an FDA-cleared medical device that is a safe, prescriptive non-drug alternative to opioids. However, when the process is disturbed at any stage, a chronic wound may result.4 A variety of factors can contribute to nonhealing, including infection, inadequate pressure relief, uncontrolled swelling, impaired blood supply, malnutrition and poor glycemic control. The Provant Therapy System is an electromagnetic medical device intended as an adjunctive treatment for post-operative pain and edema in superficial soft tissue. Provant uses pulsed electromagnetic energy to facilitate reduction of the pain and edema associated with post-operative, superficial soft tissues.