FDA panel: Neuronix Alzheimer’s therapy fails to prove efficacy

An FDA advisory panel has recommended against granting de novo clearance to Neuronix’s NeuroAD system intended to slow the progress of mild to moderate Alzheimer’s disease.

NeuroAD is approved for use in Europe, Australia and Israel, but the panel found that while it met FDA safety standards, clinical studies did not prove that it is effective.

NeuroAD uses focused transcranial magnetic stimulation (TMS) to stimulate target areas of the brain responsible for cognitive functions impaired by Alzheimer’s disease, according to the Yoqneam, Israel-based company. This stimulation is designed to induce long-term potentiation, which the company said is associated with learning and memory processes, and makes these areas of the brain more receptive to cognitive training. Patients who receive the stimulation simultaneously receive such training.

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FDA updates docs on review of paclitaxel devices for PAD

FDA-logo-newThe FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices.

In a letter to healthcare providers, the U.S. regulatory agency reported that there was a 50% increased risk of mortality in people treated with paclitaxel-coated devices versus those treated with control devices in the three trials with five-year follow-up data.

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Think Surgical, United Orthopedic join forces for global sales

Think Surgical and United Orthopedic have announced a global joint marketing agreement of Think’s Active robotic system and United’s U2 knee system.

Think’s Active robotic system consists of a 3D pre-surgical planning workstation and its computer-assisted Active robot. Its use in total knee arthroplasty is the subject of an FDA investigational device exemption study, with clearance anticipated in 2019. The system’s core technology has been used in thousands of total hip and knee replacements worldwide, according to Fremont, Calif.-based Think.

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FDA ramps up scrutiny of materials in medical devices

(Image by Michael Longmire on Unsplash)

The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances.

It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ “The Implant Files” series ripped the agency and the industry over patient injuries attributed to faulty devices. The FDA has been particularly faulted for its 510(k) clearance pathway, under which it allows devices that are similar to previously approved technology to undergo a less strenuous review before they can be sold.

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U.K., French regulators probe safety of paclitaxel devices

MHRATaking a note from the FDA, U.K. and French regulators are investigating the safety of paclitaxel devices for the treatment of peripheral artery disease.

Last week, the U.K. Medicines and Healthcare Products Agency said it ordered an inquiry into the safety of these devices following the publication of a meta-analysis that suggested a heightened risk of late mortality in people treated with paclitaxel devices compared to bare devices.

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FDA issues ‘leap-frog’ guidance on brain/computer interfaces

A researcher instructs a patient on how to move an artificial hand using a brain/computer interface device.

FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch.

FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used to demonstrate that potential risks have been mitigated before beginning a clinical study. It also provides detailed recommendations on preparing to submit an application for an investigational device exemption.

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Surgical staplers and staples linked to 41K+ injury or malfunction reports

FDA-logo-newFDA said today that it has received more than 41,000 adverse event reports — including 366 deaths — associated with surgical staplers and staples for internal use, and that it may require stricter product review of the devices.

The agency’s ongoing analysis of stapler- and internal-staple-related adverse event reports from Jan. 1, 2011 to March 31, 2018, also revealed more than 9,000 serious injuries and over 32,000 malfunctions. FDA attributed many of the problems to the staplers themselves because proper staple formation depends largely on proper function and use of the stapler.

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Saranas’ Early Bird catches nod from FDA

Saranas said today that FDA has granted its Early Bird endovascular bleed monitoring system de novo designation.

The Early Bird device includes a vascular access sheath with embedded sensors that are designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, such as TAVR, large-bore hemodynamic support device placement, or other complex cardiovascular interventions in which the femoral artery or vein is used to obtain vascular access. The technology was invented at the Texas Heart Institute.

A recent study of more than 17,000 large-bore transcatheter interventions from the National Inpatient Sample Database revealed that one in five patients experienced a bleed complication, according to the Houston, Texas-based company. A 2017 article in the Journal of the American Medical Association (JAMA) reported a three times increase in mortality, two times increase in length of hospital stay and 60 percent increase in healthcare costs of procedural bleeding after percutaneous interventions using large-bore catheters, it added.

“Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications,” said company president and CEO Zaffer Syed in a prepared statement. “As the first and only device on the market for early bleed detection, we have the potential to significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures.”

In an animal study to support FDA review of the device’s effectiveness, the Early Bird was able to detect internal bleeds with 100% sensitivity and 100% specificity, according to the company.

“Bleeding remains an Achilles’ heel of advancing minimally-invasive, catheter-based procedures,” said Dimitrios Karmpaliotis, M.D., director of chronic total occlusions, complex and high-risk angioplasty at Columbia University Medical Center, in the statement. “The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real-time.”

“Peri-procedural bleeding associated with endovascular procedures has a significant impact on patient safety and adds incremental costs to the healthcare system with longer hospital stays and additional interventional treatment,” added Saranas chief medical officer Philippe Généreux, M.D. “I firmly believe the Early Bird bleed monitoring system will help protect, and in some cases, save the lives of patients undergoing an endovascular procedure by allowing physicians to detect the onset of bleeding early and take appropriate steps to address the bleed before detrimental, irreversible and life-threatening consequences occur.”

The Early Bird is currently being piloted in multiple centers to assess its ability to potentially increase patient safety with improved bleed status monitoring during and after endovascular access procedures. Saranas plans a limited commercial launch of the device in the U.S.

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Patient deaths prompt renewed warning to heed LifeVest alert

Zoll Medical FDA has issued another update to a previous voluntary recall of Asahi Kasei (TYO:3407) subsidiary Zoll Medical‘s LifeVest 4000 wearable automatic external defibrillators following two patient deaths.

In January and July 2018, the agency and the company advised patients to contact Zoll immediately for a replacement if their device displays the message: “Call for Service—Message Code 102.” The alert indicates that the vest may have an electrical issue that causes it to fail to deliver an electrical shock to restore the patient to a normal heart rhythm.

In January 2019, FDA approved Zoll’s new software update with a more prominent and persistent patient alert for “Call for service – Message Code 102” that instructs patients to call Zoll immediately for a replacement LifeVest. The company also issued a letter to health care providers regarding the software update.

FDA said today that it learned of two patient deaths due to the LifeVest’s failure to deliver treatment as expected after Message Code 102 was displayed. The second death was reported to the agency after Zoll issued its letter on January 8, 2019. However, both deaths occurred with devices that were in use prior to the new software update, which the agency said Zoll is in the process of implementing.

The LifeVest 4000 is the only wearable cardioverter defibrillator currently available in the United States and is used by adults and children who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator.

FDA said it believes that the new, more prominent and persistent patient alert for “Message Code 102” will help increase awareness of the potential hazard and increase the likelihood of a patient contacting Zoll immediately for a replacement device after the alert appears on the device screen.

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Sotera Wireless adds tools to patient monitoring system

Sotera Wireless said it has upgraded its ViSi Mobile patient monitoring system to detect atrial fibrillation, ventricular fibrillation and ventricular tachycardia, and to provide asystole analysis.

Often asymptomatic, atrial fibrillation may remain undiagnosed until or even after the development of complications, such as stroke. Post-operative atrial fibrillation is the most common arrhythmia that occurs after both cardiac and noncardiac surgery and is associated with increased morbidity, longer hospital stays and higher hospital costs.

ViSi Mobile was previously FDA-cleared to monitor continuous noninvasive blood pressure (cNIBP), functional oxygen saturation of arterial hemoglobin (SpO2), heart rate, pulse rate, ECG activity, respiration rate and skin temperature in hospital-based facilities.

The upgrade, ViSi Mobile 1.5G, was also cleared to track and alert medical personnel to undesirable patient positions, patient immobility, and patient falls as well as display patient movement and posture (stationary, reclined, lying-down or walking), the company said.

San Diego-based Sotera Wireless emerged from bankruptcy protection in 2017 with nearly $32 million in hand, after a lawsuit brought by rival Masimo (NSDQ:MASI) drained its coffers.

Sotera filed for Chapter 11 bankruptcy protection in September 2016, saying it owed its main creditors roughly $13.1 million. Sotera reported raising about $20.7 million back in April 2014 and acquired sensor developer Reflectance Medical for an undisclosed amount the next year.

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