A Note from Vascular Cures:
While much of the world and our lives have been on hold this year, it is heartening to know that new technologies with the potential to dramatically improve, or even save, the lives of vascular patients have continued to advance. Vascular Cures and The Way to My Heart are particularly excited about certain mission-aligned improvements on the horizon, which is to say those that focus on prevention, patient empowerment, and have a meaningful impact on patient lives. Across the board, these technologies have the potential to truly transform the way we prevent, diagnose, and treat vascular conditions outside of the heart. Innovators are developing tools and programs to spot chronic vascular ailments and dangerous diabetic ulcers sooner, to treat the most critical limb-threatening artery blockages in a minimally invasive way and improve rehab compliance through innovative at-home programs.
One of the greatest factors driving innovation around prevention and early diagnosis is exciting legislative advancements that will enhance the impact of screening technologies (e.g. Podimetrics and DermaFlow). 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. The rationale and hope are 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.
In 2021, across the industry, we are looking forward to seeing major transformations in earlier PAD and stroke prevention, access to newer and potentially more durable minimally invasive life & limb saving treatment options, and greater patient compliance to every vascular specialist’s prescription of ‘walking as medicine.’
Here’s to a New Year with new hope from new breakthroughs. Check out our ones to watch in 2021. As part of our ongoing Vascular Innovation Series in conjunction with The Way To My Heart, journalist Kym McNicholas and Vascular Cures CEO Megan Patterson compiled a list of the Top 10 Vascular Innovations to Watch in 2021. And if we missed one, please share your favorite new vascular innovations in the comments.
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
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
When a physicians 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
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
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
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.
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. https://www.see-mode.com/
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