Model Monday's: Diana Moldovan
FDA Gives Breakthrough Device Designation To VenoValve For CVI
FDA continues to make use of its breakthrough device designation program, which was created in response to the 21st Century Cures Act and replaces the agency's previous expedited access pathway and priority review for medical devices. This week, the agency granted breakthrough device designation status to Hancock Jaffe Laboratories' VenoValve for the potential treatment of severe chronic venous insufficiency (CVI).
The Irvine, CA-based company has completed a first-in-human study of the VenoValve, and is finalizing plans for a U.S. Pivotal trial, SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis).
Hancock Jaffee CEO Robert Berman answered the following questions for MD&DI about the VenoValve, CVI, and the upcoming trial.
What is the clinical need that VenoValve solves?The VenoValve addresses chronic venous insufficiency, or CVI, a disease that occurs when the valves inside of the veins of the leg fail, causing blood to flow in the wrong direction and pool in the lower legs. The pooling blood causes increased pressure inside of the veins of the leg. Typical symptoms of severe CVI include leg swelling, pain, and venous ulcers that are very difficult to heal. The vascular community has been trying to solve deep venous CVI for decades, with little success. There are currently no effective treatments for the 2.4 million people in the U.S. That suffer from severe deep venous CVI, with compression stockings being the current standard of care. We are hopeful that the VenoValve will result in a paradigm shift in the treatment of CVI, and that it will be the first of several successful products that we develop for the treatment of venous disease.
How does the VenoValve work?The VenoValve is made using a non-coronary leaflet from a pig's heart valve, and is designed to open and close under the unique pressure and flow gradients of the venous system, which is very different than the coronary system. For example, a heart valve may open and close 80 to 120 times a minute, while a venous valve is likely to open and close 9 to 20 times a minute depending on what the patient is doing. It is challenging to design a valve that can function within the unique hemodynamic environment of the venous system and will not cause thromboses. We are optimistic that we have come up with the right combination of elements for the valve and the right implantation procedure to finally bring relief to the millions of patients that are suffering from this debilitating disease.
What data supports the use of VenoValve for CVI treatment?To begin with, we have many years of experience working with bio-prosthetics. We have assembled a world-class team with expertise in venous disease and the hemodynamics properties of the venous system. In addition, because of the unique physiology of the human leg, there was no good animal model to test the VenoValve. There is no animal that walks upright on two legs and has the same calf muscle function and flow dynamics as the human leg. So after consultation with the FDA, we agreed to conduct a small first-in-human trial. That trial, which was in essence a dress rehearsal for the pivotal trial, was very successful, resulting in decreases in the backwards flow of blood (54%), and significant improvements in disease manifestations (56%) and pain (74%). In addition, we experienced remarkable venous ulcer healing, with no ulcer recurrences. The protocol for our pivotal trial is very similar to what we used for the first-in-human trial and we are hopeful that we will have similar results.
How will breakthrough device status help VenoValve?We approached the FDA early on in the development of the VenoValve and have developed a nice working relationship with them. Any time a company comes up with a first-in-class product for a disease where there are no pre-existing devices, there is a learning curve for everybody involved, and we are very appreciative that the FDA has worked with us to understand the unique qualities of the venous system and our device. Breakthrough status does a few things for us: number one, it is nice to see the FDA acknowledge the debilitating impact of CVI and the potential of our product in the treatment of the disease. It also sets up our device for priority treatment from the FDA, although we have been very pleased with the responsiveness of the FDA up until now. In addition, breakthrough device status could have certain advantages as we seek to establish reimbursement and insurance coverage for our product. The bottom line is that there are millions of patients suffering from debilitating, deep venous CVI with no current effective treatment options and any help that we can get to bring relief to these patients sooner, such as breakthrough device designation, is a good thing.
What are your plans for the pivotal trial?The SAVVE pivotal trial will consist of 75 patients at up to 20 sites. The protocol is very similar to what we used for our very successful first-in-human trial. We have had no problem recruiting sites, which consist of some of the most well-respected hospitals throughout the country and several key opinion leaders in the practice of vascular medicine. They are as excited as we are about the potential for an effective treatment for a disease that has frustrated the vascular community for decades. We expect to begin the trial in the next 60 days so anyone that wants more information about the SAVVE study, including patients suffering from CVI that might want to participate in the trial, should visit www.VenoValve.Com to learn which trial site is closest to them.
Physically Demanding Jobs Linked To Higher Cognitive Impairment Risk
If your job involves a high level of physical activity, you may be at an increased risk of dementia or mild cognitive impairment (MCI), suggests a new study, published in The Lancet Regional Health – Europe.
People with a high level of occupational physical activity have a 15.5% risk of dementia, compared to the 9% risk for people whose work involves a low level of physical activity, says the study.
The study also found that people whose work requires an intermediate level of occupational physical activity are at higher risk of mild cognitive impairment, but not dementia, per se.
The study is an analysis of data from the fourth, 2017–2019 wave, of the HUNT4 70+ Study, one of the largest collections of dementia data. It included 7,005 people living in the county of Trøndelag in Norway, aged 33–65. Of the study participants, 49.8% were women.
The authors define occupational physical activity as "[p]erforming physical activities that require considerable use of your arms and legs and moving your whole body, such as climbing, lifting, balancing, walking, stooping, and handling of materials."
They rated occupational physical activity on a scale of one to five, with one representing the least amount of such activity, and five the most.
Some of the most common occupations among study participants with exposure to intensive physical activity in their roles were retail, nursing and care, and farming.
The study's corresponding author, Dr. Vegard Skirbekk, explained to Medical News Today that the purpose of the study was to better understand the risks for Alzheimer's disease and related dementias over the course of one's life.
"Understanding [Alzheimer's disease and related dementias] risks in a life-course perspective may be important for both the general public and health service providers. The causes of dementia late in life could plausibly be found earlier in life," said Dr. Skirbekk.
Dr. Roseanne Freak-Poli, a life-course epidemiologist and senior research fellow at Monash University in Australia, not involved in this research, endorsed the study's life-course approach, saying it provides a "more comprehensive understanding of how occupational histories affect cognitive health."
As it is, she noted, "we know that the physical activity intensity of our jobs is likely to decrease as we get older, so looking across the life course provides a better understanding than measurement at just one time point."
Brain health coach Ryan Glatt, director of the FitBrain Program at the Pacific Neuroscience Institute, also not involved in the research, said he was most interested in the study's finding regarding the link between intermediate occupational physical activity and MCI.
As to why people with intermediate occupational activity are more likely to experience MCI, Dr. Skirbekk said: "We believe that it is to a large extent a matter of degree; the greater the physical strains, the higher the risks later in life."
"Whether that is MCI or dementia, I don't think this article is sensitive enough to determine," observed Glatt. "This is a very large survey. It's just kind of a signal."
The researchers considered education, income, marital status, health, and lifestyle-related factors in their analysis.
"I think what this really might be signaling is a relationship between what kinds of people and which sociodemographic statuses are working these types of jobs," Glatt told us.
The authors themselves write that "the association between occupational [physical activity] and late-life cognitive impairment could be confounded by differences in socioeconomic status."
In addition, asked Glatt: "Is it possible that more physically demanding jobs, let's say construction work, could be more stressful? Yeah, absolutely. Is there a likelihood of maybe exposure to certain environmental toxins in certain jobs that might have physical activity possibly?"
"I don't think I could just go up to someone and say, 'Hey, I think you should find a desk job because this job is going to give you dementia,'" said Glatt.
So, what can a person with a physically demanding job do to protect their cognitive health?
Dr. Skirbekk said, "we believe that when one has autonomy and can take breaks, as well as having a sense of control over one's physical demands, may lower risks."
Meanwhile, Dr. Skirbekk added, following standard advice for dementia risk factors makes sense: "Avoid smoking, excessive alcohol intake, social isolation, [prevent or treat] high [blood pressure], diabetes, depression, [avoid] physical inactivity, use hearing aids in case of hearing impairment, and reduce exposure to air pollution."
Glatt suggested making sure one gets structured exercise on their time off, even if their job is physically demanding. He recommended aerobic exercise, strength training, and neural motor exercise.
Sleep, he said, is also critical to cognitive health: "A lot of people have theorized and have researched that when individuals are more physically and cognitively active, it increases the hunger and the drive for sleep."
It is also the case, he said, that this study is part of larger conversations we need to be having. "Occupational risks are really interesting, environmental exposures are interesting, job stresses are interesting: the relationship between what's good about a job, and what's bad about a job."
He called for "more occupational research on what kinds of jobs contribute to longevity, as well as health outcomes."
"And I think if we are able to understand the relationships between those factors better — such as physical activity and stress and cognitive activity — I'm hopeful we can understand yet another factor of what might contribute to someone's brain health journey."
– Ryan Glatt
Your Guide To Mild Rosacea And Its Symptoms
Though it can cause discomfort, mild rosacea is often able to be managed by lifestyle changes and gentle skin care.
Having sensitive skin can be frustrating. It can seem like the slightest things cause unwanted irritation. Unlike eczema or contact dermatitis which can occur anywhere on the body, rosacea is usually limited to your face.
As with other dermatological conditions, rosacea sits on a spectrum. Some people have severe cases while others can be more mild. Depending on the severity of your case, you might require prescription medications to control your rosacea or may be able to use over-the-counter (OTC) and at-home treatments instead.
Understanding the signs and symptoms of mild rosacea can help you to create a more effective plan to treat this skin sensitivity and ideally enjoy clearer skin in the future.
One of the key signs that you have rosacea is that your skin irritation is almost exclusively limited to your face. In particular, rosacea flare-ups tend to concentrate around the central face, nose, and cheeks.
Other visual symptoms can include:
Historically, rosacea symptoms were described based on how the condition presented in lighter skin tones. However, on darker skin tones, flushing may be less evident. Instead, the bumps and acne-like pustules, as well as discoloration in lieu of redness are more likely to be present.
On darker skin tones, other symptoms can include:
To date, the medical community still doesn't fully understand what causes rosacea. Experts believe that both environmental and hereditary factors might be to blame.
For environmental factors, experts know that certain behaviors can trigger rosacea:
However, some people are more genetically predisposed to experience rosacea than others. For example, the skin condition usually develops between the ages of 30 and 50 and tends to be more common in people with fair skin, blonde hair, and blue eyes.
Likewise, people with a family history of rosacea and those with Scandinavian or Celtic ancestry tend to be more likely to develop it.
While females are more likely to develop rosacea, when males do have it, the condition tends to be more severe.
Unfortunately, there is currently no cure for rosacea. However, once you receive a formal diagnosis, you can work with a dermatologist to help create a treatment plan that controls symptoms and reduces irritation.
In most cases, a physician will rely on prescription medications which usually include a combination of oral and topical cream antibiotics. Meanwhile, mild rosacea tends to be something people can treat without prescription medications.
If you haven't yet figured out your triggers, keeping a journal of the foods you eat, as well as any cosmetic products used can help you pinpoint irritants that make your symptoms worse.
OTC and at-home treatmentsFor mild rosacea, many people can turn to a combination of home remedies, OTC treatments, aesthetic procedures such as specific facials, and even lifestyle changes to control the symptoms and clear their skin.
Dietary changes can be the most straightforward and include avoiding known triggers. However, for this to be effective, you'll need to keep a journal so you can confidently remove certain foods or increase consumption of others like fiber and probiotics to combat rosacea.
Other lifestyle changes that might help to clear your mild rosacea include avoiding extended exposure to direct sunlight, switching to gentle skin care products, quitting smoking, exercising regularly, and treating any other underlying health issues.
Learn more about gentle skin care for rosacea here.
Aesthetic treatmentsAesthetic treatments such as facials that incorporate micro-needling have proven beneficial in controlling mild rosacea symptoms, like redness and inflammation.
While it shouldn't be the first method pursued, research has also shown laser treatments or light-based therapy can help to control the look of blood vessels in the skin and even control the thickening of the skin that often occurs.
Alternative medicinesAnother option that many people employ, along with the above treatments, is alternative medicine. This can include low impact activities like yoga or pilates to get active band reduce stress levels.
Meanwhile, many natural herbs are proven to reduce inflammation. For example, topical solutions such as green tea, oatmeal, lavender, camphor oil, tea tree oil, and even chamomile can aid in managing inflammation.
It's recommended to do a test spot before using any oil or herb to avoid irritation or allergic reaction.
Mild rosacea is a subtype of the skin condition that can often be managed without prescription medications. Although there is currently no cure, many mild cases can improve by avoiding triggers or switching to gentler skin care products. This is often sufficient to help control symptoms.
If you suspect that you might have rosacea, you should consider speaking with your primary care provider or a dermatologist.
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