Philips and B. Braun,  a player in regional anesthesia and pain management, recently announced the launch of Onvision, a breakthrough ultrasound guidance solution for real-time needle tip tracking in regional anesthesia. Available on the latest version of the B. Braun and Philips Xperius ultrasound system, Onvision gives anesthesiologists the confidence to accurately position the needle tip inside the body. The introduction is part of a multi-year strategic alliance between Philips and B. Braun to innovate in ultrasound-guided regional anesthesia, a rapidly growing alternative to general anesthesia.
Accurate needle placement is critical to the success of regional anesthesia procedures, such as peripheral nerve blocks, both in terms of effective pain relief and the avoidance of unintended nerve and vessel punctures or collateral damage to surrounding tissue. While real-time ultrasound imaging has proved to be a valuable tool for needle guidance, failure to optimally visualize the needle tip remains a challenge for both novice and experienced anesthetists. Currently, 10-20% of all peripheral nerve blocks are ineffective on the first attempt. By simplifying alignment between the needle and ultrasound probe, Onvision reduces the effort needed to interpret the ultrasound image. This allows the anesthesiologist to more confidently guide the tip of the needle to its target.
“Regional anesthesia is a rapidly growing alternative to general anesthesia and has the potential to improve patient outcomes as well as increase workflow efficiency in the hospital,” said Bert van Meurs, Chief Business Leader, Image Guided Therapy at Royal Philips. “By combining B. Braun’s expertise in needle design with Philips’ capabilities in real-time image guidance, we’ve created a solution to one of the biggest challenges in regional anesthesia – accurate positioning of the needle tip in the body. Our alliance with B. Braun is a strong example of our commitment to partner with industry leaders to grow our footprint in the therapy market.”
“Our customers want intuitive solutions that allow them to focus on the patient rather than the technology, so they can achieve the best outcomes. As demand for regional anesthesia grows, improved efficiency can also help reduce the pressure of an increasing workload,” said Dr. Meinrad Lugan, Member of the Board for the Hospital Care Division at B. Braun. “Onvision is a perfect example of what can be achieved through shared expertise to meet the evolving needs of our customers, bringing regional anesthesia to more patients in more hospitals worldwide.”
Together, B. Braun’s Stimuplex Onvision needles and Philips’ Onvision needle tip tracking technology indicate the position of the needle tip in relation to the ultrasound viewing plane to an accuracy of better than 3mm. A sensitive micro-sensor placed on the needle, combined with advanced signal processing and visualization techniques on the Xperius system, indicate the real-time location of the needle tip in relation to the 2D ultrasound viewing plane. The solution provides greater flexibility in needle trajectory and can reduce procedure times. The increased confidence and predictability offered by Xperius and Onvision will empower more anesthesiologists to embrace regional anesthesia as a viable and effective alternative to general anesthesia.
Regional anesthesia or analgesia involves the injection of an anesthetic in the proximity of a nerve, targeting areas of a patient’s body that are subject to surgical intervention. Regional anesthesia can have significant advantages over general anesthesia for both patients and hospitals. Patients undergoing regional anesthesia typically benefit from reduced opioid consumption and fewer side-effects, such as nausea. Moreover, regional anesthesia may lead to faster post-surgical recovery, allowing patients to ambulate or leave the hospital sooner, which benefits both patients and hospitals.
Together, Xperius and Onvision form an integrated point-of-care solution for supporting current and future needs in regional anesthesia. They are co-branded and sold via B. Braun’s global sales network, with Philips providing installation and service. Xperius is part of Philips’ portfolio of point-of-care ultrasound systems, which offers clinicians the ability to diagnose and care for their patients in any work environment. www.philips.com

Women have unique risk factors for heart disease that need to be taken into account in prevention and treatment strategies, according to a Cleveland Clinic cardiologist who led a team tasked with updating recommendations on women and cardiovascular disease for the American College of Cardiology.
Traditionally, doctors have treated men and women as the same when it comes to heart disease, but the director of the Women’s Cardiovascular Center at Cleveland Clinic, Leslie Cho, M.D., says that it is time to start thinking differently.
She explains: “For years, we’ve thought about men and women as having the exact same risk factors, namely, high blood pressure, hyperlipidemia, smoking, diabetes and family history. However, while heart disease is the number-one killer and most prevalent disease in women, women actually have very low risk in terms of the traditional risk factors.
“However, some conditions specific to women, such as endometriosis, have been found to raise the risk of developing coronary artery disease – the leading cause of heart attacks – by 400% in women under age 40.”
In compiling the updated recommendations, Dr. Cho and her team reviewed diseases that are more prevalent in women; sex-related differences in traditional risk factors; and risk factors that only women experience, such as those related to pregnancy.
Risks unique to women
In terms of pregnancy-related conditions, they noted that high blood pressure during pregnancy, gestational diabetes, preterm birth and miscarriages all increase a woman’s risk of developing heart disease. Identification of pregnancy-related conditions is important, says Dr Cho, as it can help identify younger women, with low traditional-risk scores, to allow for earlier monitoring of cardiometabolic factors and management.
Hormonal conditions specific to women have also been associated with increased heart risk. One of these is premature menopause, defined as menopause before the age of 40.
Dr Cho explains: “Estrogen offers women some protection from heart disease until after menopause, when estrogen levels drop. This is why the average age of for a heart attack in women is later, at 70, as opposed to 66 in men.”
Another sex-specific risk factor is a hormonal condition called polycystic ovarian syndrome (POCS), found in one in 10 women. This is associated with cardiometabolic factors, which, in turn, are associated with increased heart disease risk. The cardiometabolic factors associated with POCS include abdominal obesity, abnormal glucose control and diabetes, elevated blood pressure, and abnormal amounts of fats – such as cholesterol – in the blood, known as dyslipidemia.
Differences in traditional risks
Regarding sex-related differences in the traditional risk-factor category, it has been found that hypertension and diabetes are strong risk factors in women. Another risk factor, high blood pressure, is more common in women over the age of 50 than in men.
Woman are also more likely than men to experience depression or mental health issues, such as anxiety and chronic emotional stress, that can have an impact on their heart health.
“We really should be treating not just the blood pressure number, or the cholesterol number, but rather treating the whole patient, including their mental health, to have a good cardiovascular outcome,” says Dr. Cho.
She adds that studies have also shown sex differences in response to treatments, and doctors need to take these into account.
Common prevention strategies
Despite the different sex-related risks, Dr. Cho points out that there are common areas where either sex can lower their risk for heart disease by making changes to their lifestyles. Among these she includes avoiding smoking, getting regular exercise – at least a 30-minute walk daily – and maintaining normal weight, blood pressure, blood lipid and blood sugar levels. She recommends a diet high in fruits, vegetables, whole grains and fish, and low in animal products, simple carbohydrates and processed foods.

When a Californian company founded by a U.S. veteran wounded in Afghanistan sought to register a new medical device this year, it turned to Europe before the United States. The European approvals system had long been quicker, the company said, but the introduction of new rules is changing all that.
 “Now it has flipped,” said Bill Colone, CEO of San Clemente-based Spinal Singularity, which hopes to launch a ‘smart’ catheter for men with spinal injuries or disease early next year after squeezing in its application under the old European rules.
Colone is part of a chorus of industry voices warning that a switch to stricter European rules governing medical devices, due to come into force a year from now, will slow or even halt the release of products in Europe that could transform patients’ lives.
Defenders of the regulations say they will not significantly complicate the process and are vital to prevent problems like rupturing silicone breast implants and debris from all-metal hip implants damaging tissue and bones.
Many patient advocates say the new rules do not go far enough to reform a European system in which a top U.S. official suggested in 2011 patients may be “guinea pigs” here. The comment drew a sharp response from the European Union, which still firmly rejects that characterization.
That transatlantic spat, and the subsequent evolution of medical device certification around the world, are part of a wider global struggle by governments to attract businesses seeking light-touch regulation without scaring off their voters.
The new medical devices rules agreed by the European Union in 2017 will tighten control of devices before they come to market, improve transparency and strengthen surveillance by national authorities, a European Commission spokesperson said.
The new system changes less than some proposals – which envisaged regulation by a public body, along U.S. lines, replacing the existing practice of certification by profit-making private firms.
But players in medical technology – which ranges from surgical implants to scans – say it is too burdensome and is being built too slowly, risking not only hampering innovation but also harming patients by interrupting supplies.
“Immediate action is needed now to avoid severe disruption of product supply to patients and hospitals,” seven European Associations said in a joint statement last week.
All 55,000 devices certified under the old directives have to be re-certified along with other products such as reusable scalpels, nasal saline sprays and dental imaging software.
The industry says there are not enough Notified Bodies – the private firms charged with certifying the safety of devices ranging from bandages to pacemakers, and that manufacturers may have to take products off the market or delay new launches.
Reutershttps://tinyurl.com/yyqe7pp3