Early diagnosis, less invasive treatments, and remote rehab standout as the most significant areas in which strides are being made in vascular health as we head into 2021.
Why do we care about vascular health?
For starters, COVID 19 has shed light on the poor vascular health around the world, with the majority of serious complications being experienced by those suffering from vascular diseases such as Cardiovascular Disease, Peripheral Artery Disease (PAD), which is a narrowing of the blood vessels in mainly the legs due to plaque build-up much like it is with CVD in the heart, and diabetes.
YES, diabetes!
More than 50% of people in the U.S have pre-diabetes/diabetes, which is a blood disorder characterized by too much sugar in the blood which ultimately damages the vessel wall triggering the body’s inflammatory response to patch the damage with cholesterol and fats. Those patches build-up and voilà, vascular disease -- the #1 complication of diabetes, which is inevitable if sugar levels are not under control. And researchers don’t expect the problem to get any better with predictions for one in three American adults to have diabetes by 2050. That means innovation in vascular health is critical.
Obviously more needs to be done in prevention, diabetes included.
But do we really need technology innovation for that?
How about purely education and increased access to healthier food options particularly in food deserts where patients are most vulnerable?
What about a more integrative approach to healthcare, with the assignment of a dietitian and covered annual appointments for each patient from the get-go as is a primary care physician – or simply expanding the requirements for each primary care physician to get their medical degree to include advanced dietary and nutritional coursework?
There’s still a lot that can be done from a purely manual and policy standpoint.
Where I see the greatest technological advancements that could be designated as part of the preventative process is in early diagnosis. The right diagnostics sooner rather than later can not only put more tangible risk factors on the radar for the doctor to monitor the patient and provide early treatment, but also help facilitate that critical life-changing conversation between doctor and patient that may inspire someone to eat healthier and exercise, thereby reducing their risk of developing life-threatening complications from diabetes and vascular diseases if they even end up developing them at all. Genetics are no exception.
A big concern I have is that even with these advancements in early diagnostics, will doctors use them? Many won’t even take the time during an annual check-up to grab a simple blood pressure cuff off the wall and place it on their patient’s leg and arm and measure the differential in order to determine a patient’s risk for Peripheral Artery Disease (PAD), one of the most debilitating diseases most have never heard of yet impacts one-in-twenty Americans over the age of 50 and a third of diabetics over age 50. Most don’t know they have it until it’s reached advanced stages, if they ever find out.
Three-in-five people who suffer a heart attack have PAD, but many go undiagnosed. If only their doctor would’ve taken a moment to just check their leg pulses, maybe steps could’ve been taken to reduce their risk of heart attack, even stroke and amputation due to vascular complications not caught or managed soon enough. Standard healthcare system protocols, including questions about cost-effectiveness of early diagnostics such as this, as well as limited training for primary care physicians on various vascular diseases in medical school, impact a physician’s ability to diagnose chronic vascular illnesses before they reach advanced symptomatic changes.
If it’s legislative action that is required to inspire physicians and healthcare systems to do the right thing, well that’s happening. In 2020, Representative Donald Payne introduced the Amputation Reduction and Compassion (ARC) Act which would allow Medicare or Medicaid beneficiaries who are at risk for Peripheral Artery Disease (PAD) to get their PAD screening covered without any cost-sharing requirements. That’s good news for screening technologies such as Dermaflow and Podimetrics who made it on our “Top 10 List of Vascular Innovations To Watch in 2021.” The theory behind this legislation is that early detection will lead to early minimally invasive treatments and ultimately prevent needless amputations, especially in the most vulnerable communities where African Americans have the highest limb loss rates.
The gold standard for restoring blood blood flow whether in the legs or the heart has traditionally been bypass because of its durability lasting five, 10, sometimes even 20 years. But it’s not always the best option for patients because there are a lot of risks that go along with a major surgical procedure. That's why so much effort over the last 20 years has been placed on advancements in technology that can be used to treat artery blockages using less invasive means. The so-called "endovascular" procedures, which are performed through a keyhole entry, typically in the wrist or groin, where doctors can send catheters, wires, balloons, to restore blood flow in a minimally invasive way, are already frontline as treatment for a narrowing of vessels in the coronary region. Thanks to significant advancements in the quality of balloons, stents, and atherectomy devices (plaque removal), these procedures are better, safer, faster, and more cost-effective than bypass for coronary blockages. If a physician can’t penetrate the blockage using a guidewire, and entering into the vessel wall and creating a new channel using balloons and stents isn’t possible, bypass can still be performed.
When it comes to legs, advances in tools and techniques have lagged that of the heart. Although, I would argue that after observing thousands of hours of procedures to unblock leg arteries in nearly two dozen States and nearly a dozen countries around the world by dozens of doctors, I’ve learned amazing life and limb-saving tools & techniques, that when performed correctly, have proven to be durable life & limb saving options for patients. Knowledge of these newer tools and techniques, however, is what's actually lagging, taking longer than it should to trickle down to the gatekeepers of healthcare. They include primary care physicians who need to think twice whether to send their patient to a traditional surgeon for bypass first or allow an interventional specialist trained in newer techniques with access to newer tools have the first attempt to unblock leg arteries with in a less traumatic way. Also, insurance companies and healthcare administrators who handle the books and create the standard protocols that dictate treatment options that favor more invasive procedures as frontline treatment need to start realizing the value of newer minimally invasive techniques as frontline treatment, taking into consideration:
I’m hoping that newer, more novel bypass approaches (such as ones in our Top 10 list below) that can be performed through a keyhole entry in the leg versus a large incision, will ultimately inspire more vascular surgeons to choose an endovascular approach as frontline treatment for legs as it is in the heart for narrowed vessels.
Wait… let me modify that ‘frontline’ treatment statement to place ‘intervention’ behind what all vascular specialists prescribe, which is “walking as medicine.” That is the best frontline treatment as long as patients have at least some peripheral flow in their legs. When a main artery is narrowed and you continue to walk, it signals the body to form new routes for blood to flow that can keep the leg nourished. Every step someone takes helps the body facilitate the growth of what are called, "Collateral Vessels." It's kind of a 'Do-it-yourself bypass.' For many patients, critical lifestyle changes including exercise and diet can make a huge difference extending the time before an intervention might be required. Getting patients to do it is not always easy, which is why innovation around rehab programs is critical.
Remote rehab with real-time monitoring has proven successful in clinical studies and will remain a big focus of research and innovation in 2021 and beyond.
Innovation around remote rehab, early diagnosis, and greater interventional limb salvage are the most significant areas to watch in 2021. See below for the “Top 10 List of Innovations To Watch in 2021,” put together by independent nonprofits Vascular Cures and The Way To My Heart below. Feel free to leave any we’ve missed in comments and we will follow-up with those companies to check-out their potential in saving life & limb.
DERMAFLOW
Peripheral blood flow is essential to healthcare and wellness, as its vital role is to provide the over a trillion cells in your body with nutrients and oxygen, plus remove cellular wastes.
Without this, an individual could not survive, as his/her cells and organs would simply collapse and die. When peripheral blood flow is not sufficient or impacted otherwise negatively, that is the point in which health deterioration sets in. To be able to monitor the peripheral blood flow and correlate its changes to a specific disease state or health condition provides a HUGE advantage for early detection of deterioration over a broad medical platform. Dermaflow has developed a technology to measure this peripheral in a way that could help reveal the earliest signs of chronic vascular ailments, especially Peripheral Artery Disease.
DermaFlow, though still an early stage, pre-revenue company, has already developed a product line, Perichek™, which includes sensors both disposable and reusable, and devices with one sensor which can be modules for embedding into other devices or a handheld form, or a portable table-top version, Perichek Multi™ with multiple sensors for simultaneous monitoring. They are working on a patch type of wearable, Perichek Patch™ which will be Blue-Tooth-enabled, and have appropriate software for smart devices (i.e. cell phones) but also for PCs. These are yet to be commercialized but they’re efforting partnerships this year for the home monitoring product.
Dermflow CEO and BOD member Irene Jaffe, Ph.D. shares the backstory behind Dermaflow, its products, their potential impact, and commercialization plans. VIDEO: https://youtu.be/CyTjS76qPto
ALUCENT BIOMEDICAL
Could Alucent Biomedical soon make the well-known ‘stent,’ currently used to maintain diseased arteries and veins open, obsolete? Stents can sometimes trigger an inflammatory response leading to more build-up in the artery that blocks flow, compromising their lasting impact. Alucent has developed a more natural option to keep the vessel open: technology activated by a deep blue light that creates a scaffolding inside the vessel.
AlucentNVS is designed to deliver immediate restoration of the vessel’s lumen and sustained improvement of blood flow, without the introduction of a foreign implant, such as a metallic stent, into the patient’s body. Because there is no rigid foreign material, the arterial wall has the potential to retain its natural functionality and flexibility and avoid the complications of permanent stents. Alucent NVS photoactivated linking is also designed to mitigate the well-known adverse effects of angioplasty, such as vessel recoil. Sustained, improved blood flow may result in pain relief, limb preservation, a reduction in reinterventions and an improved quality of life for patients.
In this interview, CEO Dr. Myles Greenberg describes this exciting new technology and the path to patients, with first-in-human clinical trials launching earlier this year. VIDEO: https://vimeo.com/464391952/1a9f39fbe2
LIMFLOW
When a physician says, “There’s nothing else we can do to improve blood flow to the foot and amputation is the only option,” LimFlow is testing out a technology that could provide that ‘Hail Mary’ for patients with Critical Limb Ischemia.
Arteries naturally deliver blood flow to the foot and veins are responsible for outflow. LimFlow’s system allows for crossing from artery to vein in below-the-knee vessels to re-route blood flow to the foot. Forward flow is enabled in the vein by a disabling of the venous flaps. An extension stent is placed to keep valves in the calf open and block smaller veins from taking that blood flow in the newly converted vein back to the heart.
The LimFlow System received CE Mark in October 2016 and is commercially available in Europe. It’s approved for investigational use only in the United States. The pivotal PROMISE II clinical trial of the LimFlow System is currently enrolling patients at centers across the U.S. VIDEO: https://vimeo.com/229299140
PQ BYPASS
While LimFlow is taking an artery-to-vein bypass approach below-the-knee, PQ Bypass has found a golden opportunity using a similar approach in tackling what are considered the "Achilles heel" of percutaneous interventions in the leg, long and complex lesions in the superficial femoral artery (SFA). The difference is that PQ Bypass' Detour System does not fully arterialize the vein, but utilizes a proprietary self-expandable covered stent graft that only occupies a portion of the vein, allowing for simultaneous flow nourishing the leg and returning to the heart. The DETOUR System includes a PQ Crossing Device that allows for artery-to-vein-to artery crossing which is followed by a series of proprietary TORUS Stent Grafts being deployed from the popliteal artery to the femoral vein and then back into to the superficial femoral artery at the proximal margin of the lesion, near the ostium.
The Detour Procedure is designed to be a viable minimally invasive alternative for tough calcified occlusions in the SFA, an especially desired option for patients who are unwilling or unable to receive an inpatient procedure known as Fem-Pop bypass to re-route flow around the blockage in the SFA. A Fem-Pop bypass is a major surgical procedure which requires one or two large incisions and a vein or man-made conduit to be sewn onto both the femoral and popliteal arteries so that blood can reach the lower leg. The Fem-Pop bypass has been considered the gold standard because it’s durable, lasting five years or more in more than 70% of patients. But recovery is long, complication rates are high, and options are few if the bypass fails, especially if the disease has progressed. Plus, as the Detour procedure is usually performed under conscious sedation, patients with conditions such as COPD who are unable to receive the full sedation necessary for a surgical procedure are generally able to undergo the Detour Procedure.
The DETOUR System is an investigational device that is undergoing clinical trials (DETOUR1 and DETOUR2) after receiving "Breakthrough Device" designation from the FDA as the world's first fully percutaneous femoral-popliteal bypass device. https://vimeo.com/182166624
SPECTRUM ANTIMICROBIALS
The leading cause of amputation in the US is diabetes-related wounds that don’t heal due to infection. Antibiotic resistant bacteria are often to blame. Resistance occurs when bacteria change in response to the use of certain medicines and, over time, the medicines can’t tackle new mutations. Once antibiotic resistant bacteria set in, treatment options for a patient are limited. Spectrum Antimicrobials is trying to change that.
Spectrum Antimicrobials has developed a solution that mimics the body’s own immune system by producing hypochlorous acid (HOCl), a natural occurring chemical produced by white blood cells to fight infection caused by invading pathogens. It is also free from alcohol, steroids, antibiotics and has been clinically proven to be non-toxic. They’re first product Vetricept, is already cleared for use on animal wounds, and will be submitted to the FDA for approval imminently for use in wounds and dermatology. Other future applications also include a solution for CPAP machines and hand sanitizer to control infections with an initial focus on COVID-19. Hoji Alimi, founder and CEO of Spectrum Antimicrobials explains how he developed the product, the impact on patients, and the countless use-cases for a solution that isn’t susceptible to becoming antibiotic-resistant. VIDEO: https://youtu.be/Mf2Sv86hLa0
PODIMETRICS
A diabetic foot ulcer is one of the common and serious complications in diabetic patients. The earlier a physician knows a patient has one developing, the more likely it is that it can be treated topically and endovascular if necessary before it gets infected.
Podimetrics has designed a smart pad people can stand on daily to detect foot ulcers before they even appear. The SmartMat remotely monitors the temperature of a patient’s feet every day using their own proprietary technology. If the technology detects changes, Podimetric’s team notifies the patient and their physician to schedule a consultation for further exploration. Clinical studies show that the Podimetrics SmartMat detected 97% of diabetic foot ulcers on average five weeks before clinical presentation. Additional research within Kaiser Permanente showed the SmartMat resulted in a 71% reduction in diabetic amputations as well as a significant reductions in all-cause hospitalizations and a 40% reduction in all-cause Emergency Department visits."
Podimetrics is available to eligible patients receiving care within the Veteran’s Health Administration (VHA). It’s also available at a few private health plans. But the company is working to make it available under additional commercial payors, Medicare and Medicaid.
VASCTRAC & MOVING ANALYTICS
Walking is the best medicine for vascular diseases, especially Peripheral Artery Disease. When a main artery is narrowed and a patient continues to walk, it signals the body to form new routes for blood to flow that can keep the leg nourished. Every step a patient take helps the body facilitates the growth of what are called, "Collateral Vessels." It's kind of a 'Do-it-yourself bypass.'
VascTrac is partnering with patients to better understand their daily habits that impact their long-term prognosis with Peripheral Artery Disease. Through regular surveys and step tracking, VascTrac pinpoints and analyzes trends that ultimately could help physicians and innovators improve patient care.
Moving Analytics offers a personalized program and tools to monitor a patient’s basic stats, meds, diet, and exercise. They provide real-time coaching through texts, phone calls and e-visits, helping a patient build sustainable healthy habits.
SEE-MODE
Stroke is the #2 killer, behind Heart Disease, and the #1 cause of disability. Aside from general risk factors such as aging, smoking, heredity, and lifestyle, Doctors have been unable to predict and therefore ultimately act to prevent or reduce a patient’s risk of especially an initial stroke and 20% of second strokes. Artificial Intelligence could change that.
See Mode has developed medical artificial intelligence software for automated analysis and reporting of vascular ultrasounds scans, which is being used commercially in Singapore and piloted in Australian hospitals, but soon will more widely known in the U.S. as well. The technology harnesses the combined power of AI and fluid dynamics to objectively interpret ultrasound images and assesses blood flow patters in patients using standard routine ultrasound, CT, and MRI imaging, helping doctors detect vulnerable plaques.
MOTUS HAND AND FOOT MENTOR
Every year, nearly 800,000 people in the U.S. suffer from a stroke. It can cause severe paralysis of arms and legs requiring intensive therapy. Clinical data shows a strong correlation between the number of hours and therapy outcomes – meaning the more time a patient spends in therapy to improve their range of motion, the better their outcomes 2-3 months post stroke.
A lot of factors limit a patient’s ability to spend that extra time in-facility, including transportation, time constraints, and now COVID. So, to bring the quality in-facility therapy home to patients, including activity tracking, and gamification to make therapy fun and consistent, Motus re-designed their robotics that help patients increase mobility during stroke recovery in-facility to work at-home – and just in time for the COVID quarantine.
The Motus Hand and Foot Mentor are the only FDA Class 1 at-home stroke rehab devices that provide active assistance. Based on a patient’s needs, Motus clinicians design a personalized at-home program. Based on that program, the robotic device’s artificial intelligence and analytics technology is able to figure out a patient’s movement limitations and provide assistance where they need help in order to increase their range of motion and strength through interactive games. VIDEO: https://vimeo.com/375572996
This list is made possible through a collaboration between Vator.TV and nonprofits Vascular Cures and The Way To My Heart called "The Heart of Innovation" where we feature trends and innovators committed to saving life & limb.
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