Improving Patient Outcomes and Lowering Treatment Costs for Veterans With DVT, PE

Venous thromboembolism (VTE) incidents cause the death of up to 100,000 Americans every year. A new medical technology device has been approved for use on the Veterans Administration Federal Supply Schedule. In this commentary, Bernard Ross, CEO of Sky Medical Technology, outlines what health care professionals need to know about deep vein thrombosis (DVT) and how this new device can help deliver better patient outcomes at lower treatment costs.

The coronavirus pandemic has brought the future of global health care into focus, yet health care systems were struggling with demand before COVID-19.  As populations continue to age, breakthrough medical technology needs to bridge the gap between delivering affordable health care systems and maintaining high levels of patient care.

Fortunately, the MedTech market continues to be ripe with innovation. The United States remains the largest medical device market in the world, worth $156 billion—some 40% of the global market—in 2017. By 2023, it is expected to grow to $208 billion.¹

A growing part of the market is bioelectronic medicine.  Bioelectronics has been used in medicine from applications in pacemakers to the treatment of epilepsy and Parkinson disease.  Now bioelectronic therapies are addressing a range of other applications—including circulatory issues such as VTE.

VTE Is a Significant Health Issue

Estimates from the Centers for Disease Control and Prevention  suggest that up to 100,000 Americans die of VTE every year, with 10- to 30% dead within a month of diagnosis.² VTE’s cause issues such as DVT—typically blood clots in the deep veins of the legs, or pulmonary embolism (PE)—blood clots in the lungs.  For a quarter of people who get PE, the first symptom is death.  For those who do survive, up to half will have long-term complications such as swelling and pain.

The impact of time spent in hospital is a significant factor in VTEs.  According to World Thrombosis Day,⁴ up to 60% of all VTE cases occur during or following hospitalization.  In the US alone more than half a million hospitalized patients develop VTEs annually. Risk of VTE remains elevated for up to 30 days after discharge from hospital.

The geko™ Device Is Helping to Address VTE

The geko™ device is a wearable bioelectronic device, about the size of a wristwatch, which is applied, much like a sticking plaster, to the lower leg. It gently stimulates the common peroneal nerve, activating calf and foot muscle pumps, resulting in increased blood flow in the deep veins⁵ of the calf at rate equal to 60% of walking.⁶

It requires no external compression of the leg and enables patients to be mobile. The geko™ is the first bioelectronic device of its kind to receive US Food and Drug Administration (FDA) clearance for blood clot prevention in surgical and nonsurgical patients⁷ and has just been included on a US Veterans Health Administration (VA) Federal Supply Schedule (FSS) contract, awarded to Marathon Medical Inc.  This means the nine million or more veterans who are part of the VA health network will now have access to the geko™ device to help address significant medical issues caused by VTE.

To date people suffering VTE were treated in two ways: through blood thinning drugs or via intermittent pneumatic compression (IPC) devices. IPCs are inflatable sleeves worn on a patient’s leg that push blood around the body. However, research shows that not all patients are able to be prescribed IPC or find it intolerable to use.  For this reason, the geko™ device offers a new and real alternative for the veterans who are unable to use current treatments.

“Platform” Medicine

The geko™ device is sometimes described as a “platform” medical technology, in that it addresses more than one medical issue.  In addition to VTE, the FDA has approved clearance for the geko™ device to reduce edema.  Edema is often referred to as a “neglected public health care issue”⁸ and can be caused by issues including heart or kidney problems, a reaction to medication, or even lack of exercise.

Edema can be a particular issue both pre- and post-surgery.  In advance of surgery, patients may need to wait until swelling has subsided before surgery can take place (for example with a fractured leg or ankle) causing longer hospitalization and significant discomfort.  Many postoperative complications can be caused by edema—it can impede wound closure, decrease muscle strength, and stall rehabilitation, leading to patients having to return to hospital, sometimes multiple times.

The geko™ can be applied in both cases: in pre-operative patients this leads to quicker treatment and spending less time in hospital. Postoperative patients can be taught how to apply the geko™ device to reduce swelling more quickly.  In both cases, the device leads to better patient outcomes.

Reducing hospitalization times reduces cost associated with treatment, as does reducing the number of readmissions. Reduced time spent in the hospital also increases the capability of a health care system to treat more patients—a critical consideration as waiting lists grow post the Coronavirus pandemic.

A New Treatment for Veterans

The inclusion of the geko™ device on the VA FSS is a significant moment for MedTech devices. VA is the largest integrated health care network in the United States, treating more than nine million veterans annually at 171 hospitals.  The inclusion of the geko™ device on the FSS contract opens the benefits of the device to many health care professionals and patients who will now be able to reduce the risk of DVT or PE while in hospital or in the immediate aftermath, as well as reducing postoperative healing time.  It is also the largest deployment of the geko™ device to date and should act as a showcase to America’s health care industries of the impact MedTech devices can have.

Post-COVID Innovation

The global COVID-19 pandemic has turbo-charged innovation within health care.  The enormous impact of the virus has led to innovation in months that might otherwise have taken years, culminating in the roll out of vaccines as well as new and innovative treatments for COVID patients.

This ‘innovation urgency’ must continue.  It is rightly extremely challenging bringing new medical treatments to market—they need to be proven both clinically and financially robust.  However, building a pathway where proven platform technology is adopted quickly helps deliver positive patient outcomes across multiple medical issues.  The FSS contract for the geko™ device is an important milestone on the journey to the wider adoption of platform medical technologies. 

References:

1. Select USA. The Medical Technology Industry in the United States. Select USA website.
2. Accessed July 21, 2021. https://www.selectusa.gov/medical-technology-industry-united-states
3. Centers for Disease Control and Prevention. Data and Statistics on Venous Thromboembolism. CDC website. Updated February 2020. Accessed July 21, 2021. https://www.cdc.gov/ncbddd/dvt/data.html#:~:text=The%20precise%20number%20of%20people,(also%20called%20venous%20thromboembolism)
4. Heit JA, Spencer FA, White RH. The epidemiology of venous thromboembolism. J Thromb Thrombolysis. 2016; 41: 3–14. doi: 10.1007/s11239-015-1311-6
5. World Thrombosis Day. Accessed July 27, 2021. https://www.worldthrombosisday.org/issue/hospital-associated-vte/.
6. Griffin M, Bond D, Nicolaides A. Measurement of blood flow in the deep veins of the lower limb using the geko™ neuromuscular electro-stimulation device. Int Angiol.
7. 2016;35(4):406-410.
8. Tucker A, Maass A, Bain D, et al. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol. 2010;19(1):e31-e37. doi:10.1055/s-0031-1278361
9. FDA clears geko™ device for use in non-surgical patients at risk for deep vein thrombosis based on new data demonstrating a zero percent DVT rate in patients after a stroke. News Release. October 10, 2019. https://www.gekodevices.com/news-events/fda-clears-geko-device-for-use-in-non-surgical-patients-at-risk-for-deep-vein-thrombosis-based-on-new-data-demonstrating-a-zero-percent-dvt-rate-in-patients-after-a-stroke/
10. Moffatt C, Keeley V, Quere I. The concept of chronic edema-a neglected public health Issue and an International Response: the LIMPRINT study. Lymphat Res Biol. 2019;17(2):121-126. doi:10.1089/lrb.2018.0085