Through its innovative mechanism of bioelectronic neuromuscular electrostimulation, the geko device gently stimulates the common peroneal nerve activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the calf
The geko device (Credit: PRNewsfoto / Sky Medical Ltd)
HealingMed, importer and distributor of medical equipment and transformational innovation, has today announced ANVISA (Brazilian Health Regulatory Agency) clearance, through Mandala International, to market and distribute exclusively in Brazil, the geko™ device – the first wearable bioelectronic therapy of its kind to prevent life threatening blood clots in immobile patients and complications related to swelling after orthopaedic surgery; conditions that affect many millions of Brazilian citizens.
Estimates suggest 93,000[1] Venous Thromboembolism (VTE) related deaths in Brazil annually and a total hip and knee replacement challenge where currently 90% of patients have no dependable post-operative oedema prevention and control. HealingMed is therefore excited to bring to clinicians and the health system the geko™ device to address these significant unmet needs.
Antonio de Pádua Rocha Neto, managing director at HealingMed, commented: “The geko™ device is an exciting milestone for HealingMed and demonstrates our commitment to bring innovative technology and humanized treatments to our customers. Brazil is a large market with a significant unmet need in VTE prevention and oedema reduction. The ANVISA regulatory clearance means clinicians can now access a therapy that completely redefines the way vascular related conditions are treated across multiple care pathways.”
Bernard Ross, Sky Medical Technology Founder and CEO added, “Our entry into Brazil, Latin America’s largest healthcare market, is another important step forward for Sky. We are extremely pleased to expand our global presence to include the Brazilian market, in partnership with HealingMed, who have been a premier importer and distributor in the acute care space for over 30 years. The partnership is consistent with our goal of offering the best solutions for vascular related conditions in key markets worldwide.”
Through its innovative mechanism of bioelectronic neuromuscular electrostimulation, the geko™ device gently stimulates the common peroneal nerve activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the calf[2]. The size of a wristwatch and worn at the knee, the easy to use device operates without external pressure to the leg and allows complete patient mobility.
Manufactured by Sky Medical Technology, a UK-based medical devices company, the geko™ device has also secured INMETRO Certification, through SGS Brazil. INMETRO guarantees product compliance with Brazilian quality and safety standards. ANVISA cannot be granted without it. It is a seal of approval. The geko™ device also boasts US FDA (510K) clearance for VTE prevention across all patients including non-surgical patients, as well as UK NICE Guidance (MTG19) for VTE prevention. The intended use for the ANVISA marketing clearance is: to increase blood circulation, for the prevention and of venous thromboembolism (VTE), for the prevention and treatment of oedema
A recent study of the geko™ device to prevent VTE in acute stroke patients has reported zero VTEs in patients wearing the geko™ device, compared to 11 VTEs in patients prescribed intermittent pneumatic compression (IPC or SCDs)[3] . The findings have accelerated adoption across multiple UK NHS hospitals and international markets, providing patients with an alternative option where current standards of care are contraindicated or impractical.
Source: Company Press Release