FDA details spike in reports of breast implant-associated lymphomas
The FDA has seen a jump in the number of cases of a rare type of lymphoma linked to breast implants, which the agency says results from its efforts to educate stakeholders of the risks, as well as its work to encourage patients and providers to file reports. The cases are related to breast implant-associated anaplastic large cell lymphoma, a type of non-Hodgkin's lymphoma that can develop in the scar tissue surrounding an implant. The agency first alerted the public to the risks of the disease in 2011, and has been tracking known cases of BIA-ALCL, deaths and risk factors. As of September 2018, the FDA has received 660 adverse event reports regarding cases in the US, linked to 457 unique cases of the disease and nine patient deaths, the agency said. The total represents an increase of 246 new reports compared to the year before.
FierceMedTech, 8 Feb. 2019. http://tinyurl.com/yxcrkjf4
FDA approves Medtronic device for sealing off deeper, smaller brain aneurysms
Medtronic has received approval of an expanded indication from the FDA for its Pipeline Flex embolisation device, for patients with smaller aneurysms found deeper in the brain. The system was previously approved for endovascular treatment with large or giant, wide-necked intracranial aneurysms, located in the internal carotid artery from the petrous to the superior hypophyseal segments. The new indication includes patients with small or medium brain aneurysms, from the petrous through to the terminus of the internal carotid artery, in parent blood vessels measuring between 2 mm and 5 mm in diameter. The device is designed to divert blood away from an aneurysm, using a braided, cylindrical mesh tube implanted across the base of the aneurysm, to help reconstruct the damaged section of the blood vessel.
FierceMedTech, 8 Feb. 2019. http://tinyurl.com/y3tv86lv
Boston Scientific redesigns, upsizes mesh sling system for men with stress urinary incontinence
Boston Scientific has launched a redesign of its mesh sling system, a surgical implant for relieving stress urinary incontinence in men, to make it easier to place and available to a broader population of men. Positioned through a minimally invasive procedure, the sling compresses, moves and supports the urethra, helping the bladder to fully close. The most common causes of stress incontinence in men include complications following surgery and prostatectomies. The company's AdVance XP system includes a chevron-shaped anchoring mechanism for additional stability, as well as a longer sling length to accommodate larger patient anatomy, following discussions with urologists to identify patient needs, the company said. The new features aim to reduce slippage of the device following its placement or during physical activity, including changes to the mesh weave to help uniformly distribute the load. Boston Scientific also offers transvaginal mesh implants for treating stress urinary incontinence in women. The company has been the subject of adverse event lawsuits numbering in the tens of thousands related to its pelvic mesh products, as have other manufacturers in the medical device industry.
FierceMedTech, 8 Feb. 2019. http://tinyurl.com/y2sw396h
Arterial-pulse sensor wirelessly monitors blood flow
Stanford University researchers have developed an arterial-pulse sensor to wirelessly monitor blood flow, an advance that could allow doctors to remotely monitor the success of blood vessel surgery. The biodegradable, battery-free and wireless sensor doesn't need to be removed from a patient and can warn doctors of an arterial blockage. The compact sensor is detailed in a paper published in Nature Biomedical Engineering. According to Stanford, the sensor wraps around the healing vessel, where blood pulsing past pushes on its inner surface. As the shape of that surface changes, it alters the sensor's capacity to store electric charge, which doctors can detect remotely from a device located near the skin but outside wearable device or smartphone. The researchers first tested the sensor by pumping air through an artery-sized tube to mimic pulsing blood flow. They also implanted the sensor around an artery in a rat. The sensor then successfully reported blood flow to the wireless reader. At this point, the team were interested in detecting complete blockages, but they did see indications that future versions of this sensor could identify finer fluctuations of blood flow. The sensor is a wireless version of technology that chemical engineer Zhenan Bao has been developing to give prostheses a sense of touch.
Project aims to deliver pain-free microneedle contraception
Researchers at Cardiff University are working with partners to deliver microneedle technology that provides contraception to women in the world's poorest countries. Supported by the Bill & Melinda Gates Foundation, the consortium will focus on pre-clinical work to develop microneedle patches that have the potential to be painlessly and inconspicuously administered by the user themselves within a few seconds and can last for up to six months. Industry partners InnoCore Pharmaceuticals will utilise its biodegradable polymer platform to develop microneedles exhibiting the required mechanical properties for effective and painless puncturing of the skin, followed by contraception delivery. According to Cardiff, socio-economic and cultural barriers are preventing women from obtaining contraception even when they want to plan or prevent pregnancy. There may be a lack of awareness of the risk of becoming pregnant, and some may be deterred by the cost, inconvenience or concerns about side effects. Many simply lack access to effective methods of contraception. The Bill & Melinda Gates Foundation is funding research to address these issues and to develop practical and effective methods of contraception that are centred around the needs of the user. The grant will allow the consortium to assess the technical feasibility, usability and acceptability of the self-administrable contraceptive microneedle patch for use in the countries that need it most.
Philips unveils new EPIQ Elite ultrasound line, with vascular imaging capabilities
Philips has launched its new EPIQ Elite ultrasound system, offering a range of diagnostic solutions for different medical specialties, including the company's first for vascular assessments. Philips' solution employs its xMATRIX linear transducer to produce 3D images of the patient's vasculature, allowing clinicians to see into a vessel to evaluate plaque location and composition as well as flow data to assess stenotic conditions. The system also allows clinicians to acquire two planes simultaneously, which the company said improves accuracy and can reduce exam time by 20%. In obstetrics and gynaecology, Philips said the EPIQ Elite system provides lifelike 3D scans to offer improved detection of birth defects and potential complications during all stages of pregnancy. The system, along with Philips' TrueVue technology, allows the clinician to move a virtual light source around the 3D images of the fetus to provide high levels of detail.
FierceMedTech, 11 Feb. 2019. https://tinyurl.com/yyta3ohd
Hologic unveils mammography management software to predict X-ray equipment failures
Hologic has launched new management software for its mammography machines, which clinics can use to track performance as well as predict the potential failure of X-ray hardware and help schedule early replacements. The company's Unifi Analytics platform evaluates mammography efficiency and technologist accuracy and allows imaging centres to benchmark themselves against similar facilities. By identifying potential risks and challenges, Hologic hopes the software can help maximise device utilisation. By tracking a clinic's installed base of mammography devices, the web-based tool can predict X-ray tube failures before they occur (generally caused by electrical arcing and filament burnouts over time) allowing facilities to avoid downtime. In addition, predictive procedure volume and quality reports can notify facilities if they move off target, to help avoid regulatory compliance issues. All the data collected is de-identified in line with HIPAA privacy rules, while no personal health information is recorded, the company said.
FierceMedTech, 13 Feb. 2019. https://tinyurl.com/y4rnqa43