At Converg Medical Corporation, we want to continue to anticipate and satisfy our customer’s needs. With that goal in mind, we have compiled a list of frequently asked questions. If you do not find an answer to your question here, contact us using the Contact Us form
Is EpiFLO® in use at hospitals in Canada?
Yes, a number of hospitals in Canada have adopted EpiFLO®. In some cases EpiFLO® is an adjunctive wound care therapy and in others EpiFLO® has been used as first line treatment approach for difficult to heal wounds such as recalcitrant diabetic foot ulcers. EpiFLO® has also been used utilized in cases where long term inpatients may benefit from faster wound healing so they may leave hospital sooner had they maintained a regiment of standard wound care alone or where other therapies that were simply not effective.
 Reimbursement
How does it work?
EpiFLO® combines a specialized electrochemical process (state-of-the-art ‘fuel cell’ technology)- click the underlined text to see more), in conjunction with a membrane, to concentrate the oxygen to near 100% for continuous 24/7 delivery via a small cannula directly to ‘blanket’ the wound with oxygen. The oxygen produced continuously flows into the 152 cm (60”) long #5 Fr. cannula. The end of the cannula is placed onto the wound site and covered with an occlusive dressing or pressure dressing (see Instructions for Use). The dressing does not inflate and the patient has no sense of air movement. EpiFLO® provides silent, continuous, slow flow of oxygen (3 mL/h for either 7- or 15 days depending upon the type of EpiFLO® system used). The oxygen delivered is at a low flow rate so the wound will not dry out. Some clinicians suggest that EpiFLO® mimics the bloodstream in delivering the necessary metabolic energy to oxygen starved cells. EpiFLO® energizes ischemic cells to ‘jump start’ the natural healing process.
Oxygen blanketing the wound helps metabolically to encourage cells to form extracellular matrix components including collagen and brings about tissue regeneration evidenced by new granulation tissue, neo-vascularization and other facets of skin development.
Oxygen and Wound healing
Why use EpiFLO® in your clinical setting?
Concentrated oxygen (near or even 100%) has been clinically proven to promote wound healing. Various oxygen treatment modalities are available including Hyperbaric Oxygen Therapy [HBOT]. A major consideration for HBOT and other high-volume oxygen therapies is the limited access by patients to such treatments (i.e. ‘facility centric’). In addition, some patients may be too ill to be transported to, or undergo, the treatment within the HBOT chambers. As well, health care is moving, where possible, to a ‘distributed model’. In other words, therapies that can be moved from the acute care setting readily to an outpatient, long-term care or even home care environment are desirable. EpiFLO® has clinical use attributes ideal for distributed wound care:
- Easy to use in any health care setting - no special storage conditions, minimal training; simple ‘ON/OFF’ switch; EpiFLO® system attaches to patient in less than a minute;
- Patient benefits - apart from the effect on wound healing, the patient is free to ambulate and carry on with normal daily living activities while receiving treatment; EpiFLO® can be worn near the wound or even beneath clothing without impairing its operation;
- Safe - low volume of oxygen, no oxygen storage tanks or chambers;
- Continous treatment wherever the patient is - uninterupted and sustained delivery of oxygen 24 hour / day
- Convenient - no daily trips to the hospital to receive oxygen treatment - dressing changes (up to 7 days between) are done according to good wound care practice;
- Effective - May be used for a broad list of wound indications;
Benefits
What about the economic implications of using EpiFLO®?
Patients presenting with various delayed or chronic wound healing indications can have a variety of co-morbidities and / or complications which can affect wound healing outcomes. EpiFLO® has been shown to bring about a significant renewal of wound healing in patients with failed healing (mean duration of wounds ca. 67 weeks) with a mean time to healing of about 7 weeks. Benchmarking using independent government analyses, signicant cost-savings to the health care system can be potentially captured by use of EpiFLO® along with bringing a better quality of life outcome for the patients. Finally, avoidance of lower limb amputation by healing chronic wounds can save very significant human and financial costs. Please speak to a representative for more details on the economics for use of the EpiFLO® therapeutic modality.
Does EpiFLO® have regulatory approvals?
EpiFLO® is regulated as a Class II Medical Device by Health Canada (HC) and does not require a physician order or prescription. In the United States, EpiFLO® is regulated by the US Food and Drug Administration (FDA) and is restricted to sale by or on order of a physician. |
