Eko Core Digital Stethoscope

Eko Core, the digital stethoscope from Eko Devices, a Berkeley, CA firm. It’s much more than a high-fidelity amplified stethoscope. You can store and share auscultations, as well as analyze and annotate them using a paired app, which wirelessly connects to the Eko Core. You can even listen to recordings shared by other clinicians through the Eko Core, so you can hear exactly what they heard when they conducted the exam.

Everything can be stored to an electronic medical record (EMR), just like a radiologist would save patient CT scans, and these can be compared during future exams. The data can even be live-streamed for tele-medicine applications, such as allowing cardiology specialists to help to diagnose patients in remote and understaffed clinics. All the sharing and streaming is done using HIPAA-compliant software, allowing it to be used and integrated into existing clinical practices and their IT systems.

When you get your stethoscope, you download the app and connect the stethoscope to your iPhone, iPad, or Android device via Bluetooth.

When you perform an auscultation exam, keep your iPhone handy: the software will automatically navigate you to record, store, or share the sounds. You can annotate and attribute recorded sounds to specific regions of the chest or back, say aortic valve region for heart sounds, or upper left for lungs. (Attributing sounds to specific locations is optional. You can just record the sounds on their own if you wish to.)

The sharing part is HIPAA compliant, and you can share the recordings with colleagues or save it to an EMR. You can also receive recordings from other clinicians and hear them right there in the stethoscope. So the stethoscope is not only a recording device, but also a playback device.

Medical Robotics Shows Off Its New Versius System

Cambridge Medical Robotics, a UK firm, is revealing its Versius robotic surgery system. The system consists of modular robotic arms, any number of which can be used depending on a procedure. The arms can have a camera or any one of the dozen or so tools attached, and they can be quickly swapped for other tools as necessary.

Each of the arms can be placed around the patient table or even hung from above to save valuable space. The surgeon wears a pair of 3D glasses and operates by looking at a monitor instead of peering into a scope common on existing systems. This can help improve ergonomics and allow the surgeon to see and interact easier with clinicians managing the patient and the robot. The robot is operated using a controller similar to video game joysticks and the system delivers haptic feedback from the instrument to the controller, so the surgeon can actually feel the anatomy being worked on.

Unlike existing robotic surgical systems, the Versius can work with instruments requiring only a 5 mm incision. Typically the smallest instrument sizes on robotic systems is 8 mm, and unlike 5 mm incisions these typically require suturing and maintenance.

The company has already performed a number of studies, including on cadavers, and is compiling responses and data from 32 surgeons that has already used the Versius system. The firm hopes to receive the CE Mark in Europe in 2018 and FDA regulatory green light shortly thereafter.

SnooZeal Prevents Snoring by Training Tongue During Daytime

The SnooZeal product consists of a mouth piece that places electrodes above and below the tongue, a control unit that connects to the mouthpiece, a remote control, and a smartphone app. It works by electrically stimulating the tongue to give it a workout and keep it from completely relaxing and collapsing during the night. Snoozeal Inc. is a company out of Seattle, Washington that won the European CE Mark for its snoring prevention device.

The SnooZeal is not actually used during sleep, but indicated to be placed in the mouth twice a day for a period of six weeks. This essentially physically trains the tongue muscle and helps to keep it at least partially contracted even at night.

The device can be controlled either via the remote or through the accompanying smartphone app.

Results from multiple previous clinical trials have proven that muscle activity can be improved with this electrical stimulation technology principle.

Several studies have shown that electrical stimulation of the tongue can reduce snoring and sleep-related obstructions.

SnooZeal is the first patented product that is used entirely in the mouth and that directly stimulates the tongue muscle in order to address the root cause of snoring.

FDA Approves insulin glargine and lixisenatide

U.S. Food and Drug Administration (FDA) approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.

Soliqua 100/33 is the combination of Lantus (insulin glargine 100 Units/mL) and lixisenatide, a GLP-1 receptor agonist, in a once-daily injection, studied in a Phase 3 program of more than 1,900 patients. In an insulin intensification study, Soliqua 100/33 showed better HbA1c (average blood sugar over time) lowering versus Lantus with a majority of the 736 patients (55% vs. 30%) achieving the American Diabetes Association target of less than 7% at 30 weeks. Patients treated with Soliqua 100/33 experienced similar rates of documented (less than or equal to 70 mg/dL) hypoglycemia compared to Lantus-treated patients. The most frequently reported adverse events included hypoglycemia, as well as nausea (10%), nasopharyngitis (7%), diarrhea (7%) and upper respiratory tract infection (5%).

Soliqua 100/33 will be delivered in a single pre-filled pen for once-daily dosing covering 15 to 60 Units of insulin glargine 100 Units/mL and 5 to 20 mcg of lixisenatide using SoloStar technology, the most frequently used disposable insulin injection pen platform in the world.

FDA Approves insulin degludec and liraglutide injection

U.S. Food and Drug Administration (FDA) approved the New Drug Application for Xultophy 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Xultophy 100/3.6 is a once-daily, combination of Tresiba (insulin degludec injection) and Victoza (liraglutide) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily.1Xultophy 100/3.6 enters into a new class of diabetes treatments that combine a basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in a single, once-daily injection.

Xultophy 100/3.6 is administered as a once-daily injection from a prefilled pen and can be taken with or without food. Each Xultophy 100/3.6 dosage unit contains one unit of insulin degludec and 0.036 mg of liraglutide. The starting dose of Xultophy 100/3.6 is 16 units (16 units insulin degludec and 0.58 mg liraglutide). The maximum dose of 50 units of Xultophy 100/3.6 corresponds to 50 units of insulin degludec and 1.8 mg of liraglutide.

 

LimFlow System: A New Option for Treating Critical Limb Ischemia

If peripheral vascular disease (PAD) is not treated, it can progress toward nearly complete blockage of the arteries that supply the lower extremity with blood and result in critical limb ischemia (CLI). People suffering with the condition experience severe pain, can have gangrene, and have a drastically reduced quality of life. A new device from LimFlow, a company based in Paris, France received the European CE mark to introduce a system that can offer a new option for otherwise untreatable patients.

The LimFlow system is used to link the tibial vein and a diseased tibial artery of the leg so that blood can bypass the arterial occlusion and reach the foot. It relies on two catheters that utilize ultrasound to accurately line up next to each other. Once positioned, a guidewire from the arterial side is used to penetrate into the vein and to then place a covered stent that bridges the vessels. The stent is quite long, continuing toward the foot to provide the necessary support for all the new blood flow.

While not a miracle cure, as the patient will now have blood moving down the vein in the wrong direction, it may prevent terrible consequences such as amputation. “Utilizing the existing alternative pathway of the venous vasculature, the LimFlow System is designed to reestablish perfusion for patients that have chronic, non-healing wounds and are in imminent danger of losing a limb,” said Dan Rose, chief executive officer of LimFlow, in a statement. “We can now provide an option for patients that have none today. In early clinical cases, we have seen patients with extensive and severe foot wounds, including gangrene, fully heal following treatment with the LimFlow therapy, becoming mobile and active again.”

Pill Expands In Stomach to Stay For Weeks Delivering Medication

Many drugs require precise ingestion regimens that optimize the effect of the medication, but getting patients to follow the schedule is often easier said than done. Additionally, some drugs may work better if only they could be delivered continuously in small doses, over a period of days or weeks. At MIT and Brigham and Women’s Hospital in Boston researchers have created a capsule that expands in the stomach and delivers its drug payload in a controlled manner over an extended period of time.

It consists of a flexible hub and six drug-loaded legs that are bunched together and stuffed inside a dissolvable pill. When the pill reaches the stomach, the legs of the device open up and prevent it from leaving the stomach. This lets the slow-release mechanism within the legs to deliver the medication over a long time. After a few weeks, the hub eventually dissolves, letting each leg go and having each small piece now able to pass further down the GI tract.

Intrarosa (prasterone) to treat women experiencing moderate to severe dyspareunia

The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).

During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse.

“Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women,” said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER). “Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA.”

Efficacy of Intrarosa, a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse.

The safety of Intrarosa was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.

Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease.

Statins May Boost Survival Odds After Cardiac Arrest

The odds of surviving cardiac arrest seem higher for patients who’ve been taking cholesterol-lowering statins, a new study shows.

Researchers in Taiwan studied the medical records of nearly 138,000 cardiac arrest patients. Those already using statins such as Lipitor (atorvastatin) or Crestor (rosuvastatin) were about 19 percent more likely to survive to hospital admission and 47 percent more likely to be discharged. Also, they were 50 percent more likely to be alive a year later, the study found.

“When considering statin use for patients with high cholesterol, the benefit of surviving sudden cardiac arrest should also be considered, as statin use before cardiac arrest might improve outcomes of those patients,” said study author Dr. Ping-Hsun Yu.

Yu is a researcher from the National Taiwan University Hospital and College of Medicine in New Taipei City.

The greatest survival benefit from statins was seen in patients with type 2 diabetes, Yu’s team said.

Cardiac arrest is the abrupt loss of heart function. Death often occurs instantly or shortly after symptoms appear, according to the American Heart Association.

“We know that a large proportion of cardiac arrests occur due to coronary plaque rupture,” said Dr. Puneet Gandotra, director of the cardiac catheterization laboratories at Northwell Health Southside Hospital in Bay Shore, N.Y.

“This rupture leads to a snowball effect in arteries and can cause arteries to get blocked, resulting in a heart attack or cardiac arrest,” he explained.

So how might statins help?

“I feel that due to statin therapy, there is significant plaque stability and the effects of rupture are not as significant. Thus, an improvement in survival is noticed with patients on statin therapy who have cardiac arrests,” Gandotra said.

Statins are often prescribed for patients after a heart attack or stroke as a way to prevent a second cardiovascular event. However, “this does not mean that everyone should be on statin therapy,” Gandotra said.

These drugs can have side effects, such as muscle pain and weakness and higher blood sugar levels. In addition, the value of statins for preventing a first cardiac arrest or stroke is not clear, the researchers added.

Dr. Suzanne Steinbaum, director of Women’s Heart Health at Lenox Hill Hospital in New York City, said, “What we learn from studies like this is that [statins] have other benefits.

“A study like this gives me a reason to say, ‘There are more reasons for you to take a statin than just to lower your cholesterol,’ ” Steinbaum said.

For the study, Yu and colleagues divided the medical records of almost 138,000 patients according to whether they had used statins for 90 days within the year before their cardiac arrest. The researchers also accounted for gender, age, other medical problems, number of hospitalizations, post-resuscitation and other variables.

Because more than 95 percent of the patients in the study were Asian, these results might not apply to other groups or ethnic populations, Yu said.

The findings were to be presented on Sunday at the American Heart Association annual meeting, in New Orleans.

PR1 Peptide Vaccine May Aid Leukemia Remission

PR1 peptide vaccine may benefit many patients with myeloid leukemia, chronic myeloid leukemia and myelodysplastic syndrome, findings from an early clinical trial suggest.

As Dr. Muzaffar Qazilbash told Reuters Health by email, “This vaccine was able to induce a leukemia-specific immune response in more than half of the treated patients. These leukemia-specific T cells were probably responsible for the durable clinical responses seen in the study.”

For the study, online September 22 in Leukemia, Dr. Qazilbash of MD Anderson Cancer Center in Houston, Texas, and colleagues studied 66 HLA-A2+ patients. As well as establishing whether the vaccine was tolerated, the team sought to determine whether vaccination with the HLA-A2-restricted peptide would lead to its recognition on myeloid leukemia cells by cytotoxic T lymphocytes (CTLs) that preferentially kill leukemia and contribute to cytogenetic remission.

The patients received three to six PR1 vaccinations subcutaneously every three weeks at dose levels of 0.25, 0.5 or 1.0 mg.

Of the 53 evaluable patients with active disease, 12 (24%) had objective clinical responses. This was complete in eight, partial in one and three showed immunological improvement. Response was seen in all three disease types, but was most prominent in those with a low disease burden.

Nine of 25 patients with immune response, defined as a doubling of PR1-CTL in peripheral blood, had a clinical responders, significantly more than was the case in non-responders (3 of 28).

No grade 3 or 4 toxicity was observed and there was no association between grade 1 or grade 2 toxicity and vaccine dose level.

After a median follow-up of 10 years, 26 patients (39%) are still alive. Of the 14 patients who are in remission, 10 (71%) had an immune response to the vaccine.

“PR1 vaccine,” he added, “may also be used in patients who have achieved a complete remission after standard therapy, but are at a high risk of relapse.”

Dr. Peter Maslak, chief of the Immunology Laboratory Service at Memorial Sloan Kettering Cancer Center in New York, told Reuters Health by email, “This is a novel vaccine approach for patients with myeloid malignancies which demonstrates the ability to induce specific T cell immunity which, in some cases, translates to meaningful clinical responses.”

“Such studies provide ‘proof of hypothesis’ as we investigate incorporating non-transplant, immune-based strategies into current treatment regimens,” said Dr. Maslak, who was not involved in the work.

SOURCE: http://bit.ly/2ezHGZT