Conventional NPWT systems are passive (monotherapy) devices that only absorb wound fluid and carry the risk of drying the wound bed and driving tissue into hypoxia (oxygen deprivation).
Topivac® is a hybrid, active platform that, for the first time worldwide, combines mechanical, biochemical, and electrical stimulation within a single micro‑architectural platform.
In addition to negative pressure, it creates an artificial micro‑intensive care environment at the wound bed through programmable irrigation, topical hyperbaric oxygen (t‑HBO₂), topical ozone (O₃) gas, and an integrated TENS (transcutaneous electrical nerve stimulation) module.
When a wound occurs, the natural electrical potential of the affected tissue (injury potential) is disrupted, slowing down cellular migration. Topivac®'s patented TENS currents, which mimic endogenous (natural) electrical fields, activate healing through two primary mechanisms:
Patients with chronic wounds often experience severe nociceptive pain due to continuous vacuum pressure and frequent dressing changes. Topivac® TENS technology blocks pain signals transmitted by unmyelinated C fibers from the wound margins at the spinal cord level, in line with Melzack and Wall's Gate Control Theory.
At the same time, it stimulates both local and central release of endorphins and enkephalins. This reduces the patient's dependence on systemic analgesics while maximizing psychological and physical compliance with treatment.
On wound surfaces, bacteria form a resistant biofilm layer (glycocalyx "shield") that protects them from systemic antibiotics and immune cells. The controlled delivery of topical ozone (O₃) gas by Topivac® acts as a powerful oxidizing agent.
It directly disrupts the lipid membranes and cell wall integrity of highly resistant pathogens (such as MRSA, Pseudomonas aeruginosa, VRE) through peroxidation, leading to their destruction. Because ozone's physicochemical breakdown mechanism is non-specific, microorganisms cannot develop genetic resistance against it — making this approach biologically impossible to overcome.
In systemic hyperbaric therapy, patients must enter high-pressure chambers, which can lead to complications such as claustrophobia, barotrauma (eardrum rupture), oxygen toxicity, and high session costs. In contrast, Topivac® delivers Topical Hyperbaric Oxygen (t-HBO₂) directly to the wound site using humidified pure oxygen.
This localized approach revitalizes the metabolism of epidermal cells that have nearly ceased activity due to ischemia (insufficient blood flow), stimulates collagen synthesis, and enhances VEGF (Vascular Endothelial Growth Factor) secretion via macrophages. As a result, new capillary sprouting (angiogenesis) is initiated directly at the wound bed — without systemic side effects.
At physician-defined intervals (for example, once per hour), the device injects sterile solutions, ozonated water, or topical disinfectants into the wound bed. The fluid is sealed within the wound environment for a specific duration known as dwell time.
During this period, the solution chemically and mechanically softens and dissolves the bacterial biofilm layer. Once the dwell time ends, the device automatically switches to a powerful vacuum mode, removing the loosened bio-burden, cellular debris, and necrotic tissue into the waste reservoir.
In conventional vacuum devices, the sponge often dries out and adheres to the newly formed granulation tissue. When the dressing is removed, these fragile cells are torn away, causing the wound to bleed again and delaying epithelialization. Topivac® maintains the wound bed at an optimal moisture balance through microprocessor-controlled regulation.
Before each dressing change, an automatic humidification phase is activated. Combined with the local analgesic effect of TENS, this ensures the sponge separates smoothly from the fresh tissue — without trauma and completely pain-free.
Topivac® is definitively indicated in clinical cases that have proven resistant to conventional dressings, surgical interventions, or standard one-way vacuum devices, and that have entered the ischemia–infection cycle:
In infections like necrotizing fasciitis, which rapidly destroy fascia and soft tissue, aggressive surgical debridement (removal of necrotic tissue) is the first vital step. Following surgery, microscopic pathogen loads that remain hidden in deep anatomical spaces are rapidly sterilized through Topivac®'s combined negative pressure and topical ozone (O₃) cycles.
With the added support of TENS-induced microcirculation, tissue regeneration accelerates from the wound base upwards. This significantly reduces the patient's risk of sepsis (blood poisoning) and minimizes the acute, life-threatening danger.
Through the synergistic effects of mechanical vacuum, electrostimulation (TENS), and multi-gas therapies, Topivac® accelerates wound closure with fresh tissue by up to 50% compared to standard treatments. This radical acceleration reduces patients' overall length of hospital stay (LOS), lowers dressing and consumable usage, prevents reliance on costly systemic antibiotics, and—most importantly—avoids high-cost limb losses (amputations and subsequent prosthesis/rehabilitation processes). As a result, Topivac® delivers substantial economic advantages to healthcare budgets.
Topivac® features intelligent algorithms that can be flexibly adjusted by the physician according to the wound's current pathological condition; it can operate in synchronized, sequential (consecutive), or simultaneous modes.
For example, the device can first oxygenate the tissue via gas injection and then perform automatic irrigation; while aspirating the irrigation fluid and applying negative pressure, it can simultaneously stimulate microvessels with continuous or intermittent TENS. This multi‑mode management enhances the likelihood of successful treatment.
Absolutely not. All wound closure kits used with the system — including the smart hydrophobic/hydrophilic sponges, fluid/gas transfer lines, sealed drapes (barriers), and the special electrode leads that conduct TENS current — are single‑use, biocompatible, and sterile‑packaged. A new kit is opened for each patient. The sponge structures incorporate a specialized conductivity architecture that distributes TENS current evenly at microamp/milliamp levels to prevent electrical burns or tissue irritation.
Despite its complex hybrid technology, the device features a highly user‑friendly, touch‑based, and intuitive interface for clinicians and wound care nurses.
It includes pre‑clinically optimized ready treatment protocols (automatic protocols) for various indications such as diabetic foot, pressure ulcers, grafts, or infected wounds. After the physician selects the wound type, the device automatically manages vacuum strength, irrigation intervals, gas dosing, and TENS current parameters. This automation reduces clinical staff workload and the risk of application errors to virtually zero.
Topivac® offers clinicians precise, adjustable control with a wide flexibility range from min. -20 mmHg to max. -200 mmHg. The system supports continuous, intermittent, and dynamic negative pressure modes. In particular, intermittent and irrigation modes maximize mechanical macro‑deformation of the tissue to promote cellular proliferation, while the continuous mode is used to stabilize draining and highly exudative acute wounds.
The system uses multi‑layer polyurethane drapes (barrier films) with high sealing performance and specially designed dual‑channel pad connectors. Sensitive pressure sensors inside the device monitor the gas pressure beneath the wound closure kit at microsecond resolution. In the event of a potential leak, drape detachment, or occlusion, the device immediately triggers visual and audible Air Leak / Leakage Alarms, halts gas delivery, and thereby ensures clinical safety.
In wounds complicated by osteomyelitis, blood flow can be severely reduced due to damage in the bone cortex. The Topivac® TENS module creates an electrical potential that stimulates periosteal microcirculation in deep tissues and around bone. Increased perfusion enables systemically administered antibiotics to reach infected bone foci at higher concentrations than they otherwise would. This synergy provides a critical clinical advantage in resolving bone infection.
Topivac® waste canisters incorporate integrated hydrophobic and bacterial filter protection to prevent cross‑contamination. Infected wound exudate drawn into the canister is converted into a gel by gelling/solidifying agents, preventing liquid leakage into the environment. In addition, waste gases from topical ozone therapy are routed through specialized activated carbon and catalytic filter systems inside the canister and fully neutralized, thereby preventing any odor or gas release into the clinical area.
In plastic surgery, the first 24–72 hours after a graft or flap is adapted to the wound bed are the most critical for tissue survival (graft take). Topivac® is initiated immediately after surgery in a low negative‑pressure and t‑HBO₂/TENS mode. While negative pressure stabilizes the tissue, TENS and oxygen accelerate the opening of microvascular anastomoses. It is generally recommended to apply the system continuously for an average of 5–7 days, until the risk of marginal perfusion compromise has resolved.
Elderly patients often have fragile, delicate skin, while pediatric patients have smaller body surface areas. Topivac® provides a flexible pressure and current range tailored for these two special populations. In geriatric patients, drape adhesion and vacuum pressure are kept lower (for example, around -50 to -80 mmHg); in pediatric patients, irrigation volumes and TENS current milliamp levels are minimized at a micro‑architectural scale according to the patient's weight and age. Preconfigured pediatric and geriatric modes automatically optimize these settings.
The Topivac® Hybrid Wound Treatment System is certified as an active medical device Class IIb, fully compliant with the European Medical Device Regulation (MDR) and applicable international standards. The system has successfully met requirements under the ISO 13485 Medical Devices Quality Management System and has passed tests for biocompatibility (ISO 10993), electrical safety (IEC 60601‑1), and electromagnetic compatibility (IEC 60601‑1‑2), demonstrating full validity for global markets and hospital procurement processes. A UK FSC certificate is also available.
Topivac® employs a closed‑system architecture integrated with the device technology. The device operates only with original, sterile Topivac® wound closure kits. This design technically prevents 100% the use of non‑sterile, incompatible, or third‑party sponge/consumable products in hospitals.
From a hospital management perspective, treatment standardization and patient safety are maximized, while distributors gain full financial assurance for post‑tender consumable supply cycles.
The system is highly compatible with modern wound dressings and biomaterials, but the chemical nature of the gas modules requires a careful clinical approach:
Topivac® is designed to be fully mobile, taking into account the high circulation of patients between wards, operating rooms, radiology, and dressing rooms. The device is equipped with a high‑capacity, rechargeable internal battery.
During power outages or patient transfers, the device can sustain all hybrid functions (including TENS electrical stimulation, vacuum management, and gas injections) from battery power for up to 4 hours without interruption. The unit is very lightweight and can be easily transported without removing it from the patient.
TopiVac-Amedus; does not perform medical practice, provide medical services or advice. The information on this web site should not be construed as medical advice.
The information on this site is primarily for healthcare professionals. Patients should consult their physician and healthcare professionals for their medical conditions and treatments, as well as the information provided on this site.