For the 30 million Americans living with some form of kidney disease, the current COVID-19 pandemic brings a host of additional challenges not faced by the general population—like a greater risk of developing serious complications if they contract the virus. And for the 500,000 Americans with kidney failure who rely on dialysis treatments to stay alive, these challenges only multiply. Do they follow “stay-at-home” orders and skip their dialysis treatments, or do they risk exposure by going to a dialysis clinic where social distancing is difficult, if not impossible, to enforce? Either decision could have life-threatening consequences.
And what about the procedures to create and maintain the necessary access to their bloodstream that makes dialysis possible? In mid-March, the CMS deemed these procedures “non-essential,” leading to a host of cancelled appointments and operations. Even when CMS reversed its decision days later, the confusion that resulted from the chaos left many physicians, hospitals and patients unsure of which path to follow.
In the United States alone, nearly half a million people currently suffer from end-stage kidney disease and must undergo hemodialysis several times a week. For these patients, the vascular access site is quite literally their lifeline, as it provides direct access to their bloodstream for the life-saving treatments.
Yet due to the current COVID-19 outbreak, procedures to establish these vascular access sites have been deemed “non-essential” elective procedures by CMS and HHS, and nephrologists and vascular surgeons are finding themselves unable to secure operating room time.
Though we must all work together during this crisis to reduce the intense strain on our healthcare system, this decision could have devastating implications for patients with end-stage kidney disease — a group that is already highly vulnerable to potential complications of COVID-19. Limiting access to these procedures will increase reliance on riskier vascular access options that significantly increase patients’ chances of infection, hospitalization and even death. This will only add to the strain on resources as hospitals continue to deal with the outbreak.
Multiple myeloma is the most common hematological malignancy. It forms in plasma cells, white blood cells found mainly in the bone marrow that protect the body from infection by producing antibodies. When these cells become malignant, abnormal plasma cells accumulate in the bone marrow, producing abnormal antibodies and crowding out normal blood-forming cells. Some of these abnormal cells, known as circulating multiple myeloma cells (CMMC), escape from the primary tumor space and travel through the bloodstream.
Current approaches for diagnosing patients with multiple myeloma require bone marrow aspiration and biopsy. These are invasive procedures that use a hollow needle inserted into the hipbone or breastbone to remove bone marrow, blood, and a small piece of bone. While generally safe, bone marrow exams can result in excessive bleeding, infection, and long-lasting discomfort.
This basic fact makes IV therapy a pressing healthcare issue affecting nearly every specialty, according to Lee Steere, RN, CRNI, VA-BC, Manager of IV Therapy Services at Hartford Hospital – especially when you consider that nearly 90 percent of hospitalized patients will require a peripheral IV (PIV) catheter at some point during their stay.
In the United States, PIV failure rates average around 53%, meaning one out of every two catheters fail to last until the end of treatment. This could be the reason that needle sticks are among the top ten patient fears, according to a national survey of hospitalized patients.
Recovery from breast cancer can be a difficult journey, both physically and emotionally. An important part of recovery from the trauma of cancer diagnosis is to be able to put the entire experience in the rear view mirror, so to speak. But it’s hard to do that if you have a daily reminder in the form of a disfiguring scar.
It was once common for surgeons to focus solely on removing a breast cancer tumor with little regard for the appearance of the breast. But we now know we can deliver excellent cosmetic outcomes without compromising oncologic safety. There have been tremendous advances in the past 20 years in the diagnosis and treatment of breast cancer that enable us to help our patients look and feel better after breast cancer.
It will come as no surprise to medical device startups that the funding climate in medical devices is still challenging. We talked recently with two experts who come to this question with two different perspectives.
– Alice McKeon is VP Healthcare Investment Banking at Network 1 Financial, which is based in Red Bank, N.J.
– Dan Clark is a Cofounder and the Chief Marketing Officer at Linear Health Sciences, makers of the Orchid Safety Release Valve.
The power and policies emanating from Washington DC are on the minds of many people these days. How will the Trump Administration affect the investment climate in medical devices?
Many drivers have experienced the kind of fender-bender or sudden stop that made them glad they were wearing a seat belt. But a seatbelt can only protect us from so much — which is why airbags and more advanced safety approaches were invented.
To use another auto analogy, think of the breakaway hoses at gas stations pumps. They prevent the full hose from being pulled out of the pump when an absent-minded driver drives away without removing the nozzle from the gas tank.
With something like 300 million peripheral IV lines sold in U.S. each year – and a failure rate that’s often cited as being 50% – researchers continue to try to understand a problem that’s a daily headache in vascular access and infusion therapy.
Common causes of line failure are dislodgement, infection, thrombosis, phlebitis and occlusion. Peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) tend to be better secured than peripheral IVs, but they are also subject to high failure rates.
When a company comes up with something better, it typically wants a high profile for the technology. But it’s not always the case with Focal Therapeutics.
That’s because the company recently launched a low-profile version of the BioZorb® implant used in breast conservation treatment (BCT).
Focal’s new BioZorb LP (for “low-profile”) design means more women who need breast cancer surgery could benefit from the implantable device. BioZorb is used in “reconstructive lumpectomy” and other types of BCT. It marks in three dimensions the site from which a breast tumor is removed.
The BioZorb LP device is designed to be implanted in smaller breasts, peripheral areas of the breast, and locations with less tissue coverage.
Every time the US Preventive Services Task Force issues a recommendation about when women should start getting mammograms – and how often they should have these screenings – it sends shockwaves through the breast-cancer world.
This last time was no different.
But now two influential breast cancer experts assert that – as important as the debate is – it misses an essential point about evaluating a woman’s individual risk of getting breast cancer.
Those experts – Dallas breast surgeon Dr. Peter Beitsch and Nashville breast surgeon Dr. Pat Whitworth – say the key question is how to evaluate “risk.”