Category: Device and Test

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.”

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.

According to new research published in the American Heart Association journal Stroke, researchers at the MetroHealth System, Case Western Reserve University, and the Cleveland Functional Electrical Stimulation Center have developed a therapy whereby patients can be in control of the stimulation to their weak hand.

The electrical currents are delivered using a glove with sensors. By wearing the glove on their unaffected hand and opening their fingers, the affected side receives a similar amount of stimulation to open the weakened hand. This wearable technology put the patient back in control of their hand while enabling them to participate in electrical stimulation therapy.

“Based on positive findings from our previous studies, we sought to determine if the new glove-controlled hand stimulation therapy could be more effective than the common therapy in improving hand dexterity in patients who are more than six months past their stroke,” says Jayme S. Knutson, Ph.D., senior author of the study and an assistant professor of Physical Medicine and Rehabilitation at Case Western Reserve University School of Medicine in Cleveland, Ohio.

Almost all electrical stimulation glove users noted hand improvements

The researchers found that participants from the group that used the electrical stimulation glove presented greater improvement on the dexterity test by 4.6 blocks on average, compared with the common therapy group, which improved by 1.8 blocks.

Patients who displayed the most significant improvement on the dexterity test using the glove were less than 2 years post-stroke and had some finger movement at the start of the study. They improved by 9.6 blocks on the dexterity test, compared with 4.1 blocks in the common therapy group.

Patients with no finger movement at the beginning of the study also noted improvements in arm movement upon using the glove for the duration of the study. In total, 97 percent of participants agreed that their hand functioned better at the end of the study than at the beginning after using the new therapy.

The current research was conducted at a single site. The team aims to replicate the study at multiple sites in the future to confirm the results and also measure improvements in the quality of life for patients.

One key outcome of the investigation demonstrates that stroke patients can use the new technology to have the freedom and independence to administer their therapy at home rather than in a healthcare setting.

While the researchers speculate that the new electrical stimulation therapy’s success may be due to neural connections in the brain that control hand dexterity changing as a result of the treatment, they say that additional studies need to be conducted to verify the effect it may have on the central nervous system.

 

SEPTEMBER 23RD, 2016

In what may be a major development for some patients with epilepsy, researchers at Mayo Clinic have shown that continuous electrical stimulation of the brain’s cortex can reduce the frequency of seizures, and in some cases their intensity and duration. The study, published in JAMA Neurology relied on applying an electrode grid to the brain, essentially the same type that’s commonly used to pinpoint the source of seizures, but to use them to send an electric current to the brain. Thirteen patients with drug-resistant focal epilepsy for whom surgery would not be appropriate had temporary electrodes applied. Once they showed a positive response to the electric therapy, the electrode array was replaced with a more permanent device.

Ten of the thirteen patients had improved outcomes in both the intensity of their seizures and their life satisfaction. Majority also had a more than 50% decline in seizures compared to before therapy and six of the people had no disabling seizures at all.

Interestingly, interictal epileptiform discharges, which are electrical biomarkers that can be used to identify the source of seizures, dropped in quantity within minutes after electric current began to be delivered.

There’s still a lot of clinical trials that will need to be done to confirm these findings and to look for any potential side effects, but it certainly looks like the folks at Mayo are onto something here.

Study in JAMA Neurology: Chronic Subthreshold Cortical Stimulation to Treat Focal Epilepsy

SEPTEMBER 19TH, 2016

A unique system that uses a balloon and sound waves to break up plaque in patients with peripheral artery disease has just been cleared by the FDA. The Lithoplasty system from Shockwave, a firm out of Fremont, California, is basically a traditional angioplasty balloon catheter with added capability that resembles lithotripsy that’s used to break up kidney stones.

The transducers along the length of the balloon section are tuned to generate sound at frequencies that resonate hardened calcium. Being all shook up, the calcium deposits are motivated to crack and to allow the balloon to push them closer to the vessel wall. This results in a wider lumen and should lead to improved outcomes for patients with peripheral artery disease for whom an extra millimeter or two of increased space for blood to flow can make a whole lot of difference.

“Lithoplasty represents a new mechanism of treatment and is revolutionary for the care of patients with calcified peripheral vascular disease, a difficult-to-treat patient population,” in a statement said Kenneth Rosenfield, M.D., Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital. “Existing devices for treating these patients have significant shortcomings that make it challenging to successfully open arteries, while minimizing vascular injury and complications. Lithoplasty is a unique approach that allows us to successfully treat these diseased vessels using a device built on a familiar balloon catheter platform, while minimizing the risk of vessel injury, including dissections that require stenting or other additional interventions.”

3 Aug 2016

Use of a foot wrap to apply pressure on the abductor hallucis and flexor hallucis brevis muscles may be used as a potential therapeutic in the management of restless leg syndrome (RLS), improving the symptoms of moderate to severe primary RLS sans the negative effects associated with standard treatment agents, a study suggests.

“RLS or Willis-Ekbom disease, is a neurologic disorder causing unpleasant sensations and an urge to move the legs when at rest. Potent medications, such as opioids, central nervous system depressants, anticonvulsants, and dopamine agonists have been used to ease symptoms, each with adverse effects,” the investigators said.

Foot wrap, on the other hand, functions by applying targeted pressure on the muscles in the medial and plantar regions of the foot. It consists of a pressure pad that is held in place by an outer cloth, secured by hook and loop straps, which also serve as adjustable straps to regulate the amount of pressure. In 2013, the US Food and Drug Administration cleared the device as safe for RLS.

In the current study, the investigators evaluated the efficacy and safety of foot wrap in 30 patients (mean age 51.5 years; 73 percent female) with moderate to severe RLS symptoms. The wraps were worn on each foot for set periods intermittently over 8 weeks, as follows: baseline period without the wraps (days 1 to 7), initial treatment with the wraps (days 8 to 28), treatment interruption (days 29 to 35), and treatment resumption (days 36 to 56). Mean follow-up was 15.6 months. [J Am Osteopath Assoc 2016;116:440-450]

Primary outcome measure was mean change in the International Restless Legs Syndrome Study Group (IRLSSG) rating scale, from baseline to day 56. Secondary outcome measure was the Clinical Global Improvement Scale (CGIS) scores. Researchers performed a meta-analysis to compare the foot wrap findings with that of 3 previous studies reporting the effects of ropinirole vs placebo for primary RLS.

The foot wrap treatment arm showed a greater change in mean IRLSSG score compared with the ropinirole and placebo arms (17.22; p<0.001 vs 12 and 8.9, respectively; p<0.05). In the foot wrap arm, sleep disturbance severity decreased from moderate to mild (2.7 to 0.6), and sleep loss significantly diminished from 119.5 minutes to 22.1 minutes per night (p<0.001).

Similarly, CGIS scores improved significantly with the foot wrap versus ropinirole and placebo (90 percent [27/30] vs 63 percent [293/464] and 47 percent [218/467]; p<0.05).

There were reports of mild adverse effects in the foot wrap arm, such as pain and paraesthesia, which were attenuated by loosening the straps. Dopamine agonist treatment-related adverse effects, including augmentation, tolerance, rebound, somnolence, and nausea, did not occur with foot wraps.

The findings suggest that foot wrap “was almost twice as effective as historic placebo medication and 1.4 times as effective as ropinirole in lowering IRLSSG scores,” the investigators said.

They explained: “We believe that continued pressure on the abductor hallucis and flexor hallucis brevis muscles throughout the evening signals the brain to relax rather than contract the muscles, acting as a counter-stimulant. This theory represents a new and unique mechanism of action to suppress the symptoms of RLS. Pressure produced by the device on the muscles may also stimulate a dopamine release, similar to massage therapy or acupressure.”