16/12/2021
On 16th December 2021, we were awarded FDA clearance 510(k) to market the geko™ device for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia.
Ischemia is a condition where blood flow (and thus oxygen) is restricted in a part of the body. For instance, cardiac ischemia refers to lowered blood flow and oxygen to the heart. While venous insufficiency occurs when veins struggle to send blood from the limbs back to the heart which can cause blood to pool in the veins in the leg.
EnlargeVenous insufficiency and ischemia are both caused by reduced blood flow and can lead to lower extremity oedema, skin changes, discomfort, and in some cases can progress to chronic venous insufficiency (CVI) – a serious condition attributed to diminished quality of life and loss of work productivity.
Every year approximately 150,000 people are diagnosed with chronic venous insufficiency, costing the US healthcare system almost $500 million for patient care. If left untreated, CVI can lead to post-phlebitic syndrome and venous leg ulcers [1], ultimately costing healthcare systems more money for patient treatment.
Venous insufficiency and ischemia are preventable conditions but are common and can be expensive to treat. These factors combined indicate these medical settings are sorely in need of innovation.
Three recent studies – two led by Das [2],[3], the other led by Bosanquet [4],- demonstrate the geko™ device increased microcirculatory blood flow in the lower limbs of patients with venous insufficiency and ischemia. Both studies measured the increase using Laser Speckle Contrast Imaging, a non-invasive technique that measures blood flow.
This FDA clearance adds to our portfolio of awarded regulatory approvals in the U.S. for oedema reduction and for stimulation of the calf muscles to prevent venous thrombosis (blood clots) in both surgical and non-surgical patients.
This is a significant step forward in our journey to market the geko™ device in the U.S – one that will help establish geko™ as an industry leading wearable device applicable to a range of medical settings.
Our CEO and Founder, Bernard Ross commented, “Achieving this latest 510(k) clearance is a significant milestone for Sky that will allow us to initiate a controlled market release of the geko™ device to address venous insufficiency and ischemia in the first instance – a therapy area sorely in need of innovation. With this 510(k) and in partnership with leading US clinicians we can now press ahead to redefine the way vascular related conditions can be treated.”
References:
1. Patel SK et al. Venous Insufficiency. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan. 2021 Aug 4.
2. Das et al. Neuromuscular stimulation of the common peroneal nerve increases arterial and venous velocity in patients with venous leg ulcers. Int Wound J. 2020;1–7. DOI: 10.1111/iwj.13510. September 2020.
3. Das et al. Microcirculatory changes in venous leg ulcers using intermittent electrostimulation of common peroneal nerve, Journal of Wound Care. Vol 30, No 2. February 2021
4. Bosanquet DC et al. Microcirculatory Flux and Pulsatility in Arterial Leg Ulcers is Increased by Intermittent Neuromuscular Electrostimulation of the Common Peroneal Nerve. Published by Elsevier Inc. Open access article under the CC BY-NC-ND license. Manuscript received: May 14, 2020; manuscript accepted: July 9, 2020; published online
