Royal Philips has announced an update to its handheld ultrasound platform—Lumify—adding Pulse Wave Doppler technology to expand the haemodynamic assessment and measurement capabilities of the system.

In a press release, Philips said that the new functionality would enable clinicians to quantify blood flow in a wide range of point-of-care diagnostic applications including cardiology, vascular, abdominal, urology, obstetrics and gynecology.

Pulse Wave Doppler ultrasound provides clinicians with more information, in addition to 2D and colour imaging, to assess haemodynamic patterns to differentiate between arterial and venous blood flow and quantify haemodynamic function, Philips detailed in a press release. An additional update to the system includes obstetric measurements to help in early assessment of gestational age and the identification of high-risk pregnancies.

“By applying Philips’ expertise in cardiovascular care, imaging and patient monitoring to Philips Handheld Ultrasound—Lumify—we are committed to deliver a dedicated, innovative point-of-care portfolio, enabling clinicians to quickly assess haemodynamics—including cardiovascular function, organ perfusion and fetal assessment—in a daily routine, to identify abnormalities and intervene quickly,” said Matthijs Groot Wassink, general manager of Point of Care Ultrasound at Philips. “With the addition of Pulse Wave Doppler and enhanced obstetrics measurements, we have increased the number of markers on which diagnoses can be made, to deliver high quality imaging and enhance the evaluation and effectiveness of treatment in real-time.”

“Having Colour Flow Doppler (CFD) and Pulse Wave Doppler on a handheld device is game changing, allowing clinicians to take point-of-care ultrasound examinations to the next level,” said Robert Jones, professor of Emergency Medicine at the MetroHealth System, Cleveland, USA.

Royal Philips today announced physicians will now have access to advanced new 3D image guidance capabilities through the image-guided therapy mobile C-arm system—Zenition, aiming to improve the outcomes for patients undergoing endovascular treatment. The company has signed a strategic partnership agreement with Cydar, a UK based provider of cloud-based procedure maps software to plan and guide surgery in real time.

As patient numbers rise and procedures become more complex and time-consuming, patient-specific real-time procedure planning and guidance, optimisation of equipment utilisation, and usability have become ever more important. To help overcome these challenges, Philips claims that the image-guided therapy mobile C-arm system—Zenition—brings together innovations in image capture and processing, ease-of-use, and versatility, many of which were pioneered on Philips’ image-guided therapy platform Azurion. Like Azurion, the Zenition mobile C-arm system allows hospitals to maximise operating room performance, enhance their clinical capabilities, and provide staff with a seamless user experience, a press release details.

The integration of Cydar EV Maps software into the Zenition platform now adds extended procedure planning and real-time 3D guidance capabilities.

Cloud-based AI and computer vision

Cydar EV Maps assists in the planning, real-time guidance, and postprocedure review of the endovascular surgery. It brings cloud-based AI and computer vision to mobile surgery, enabling reductions in radiation exposure, fluoroscopy time, and procedure time together with improved ease of use, Philips states. It enables surgeons to create a detailed patient-specific 3D map of the target vasculature to help plan surgery, and then uses these maps to augment intraoperative live image guidance, updating the maps in real time to account for deformations during surgery, such as guidewires and instruments deforming the patient’s blood vessels.

Cydar EV also facilitates post procedure outcome analysis. The combined result of this integration of procedure planning, guidance and review is that surgeons can work more accurately and efficiently—enabling an approximate 50% reduction in radiation exposure, a significant reduction in fluoroscopy time and a reduction of procedure times by more than 20%, according to Philips, all while helping achieve better outcomes for patients.

“With Philips’ integrated portfolio, using validated AI and cloud technologies, we can facilitate collaborative care to optimise surgical pathways,” said Karim Boussebaa, general manager Image Guided Therapy Systems at Philips. “Philips has a strong global network of mobile surgery systems and recognises that Cydar’s EV Maps solution can play a key role in further improving our integrated offering for endovascular procedures.”

“By partnering with Philips to bring our Cydar EV Map solution to Philips’ user-friendly Zenition platform of mobile C-arms, we are a step closer to achieving our mission to ensure every image-guided minimally-invasive surgical procedure goes exactly as planned,” said Paul Mussenden, CEO of Cydar. “The benefits of this combined solution, with integrated and enhanced procedure planning and visualisation, include shorter and more predictable procedure times, reduced X-ray exposure to patients and staff, and fewer injections of iodine dye—the leading cause of in-hospital kidney failure.”

Cydar EV Maps is currently in use across the EU, UK and USA. It is certified Software-as-a-Medical Device with EU CE mark and US Food and Drug Administration (FDA) 510(k) clearances.

Royal Philips has announced US Food and Drug Administration (FDA) de novo clearance for the Philips inferior vena cava (IVC) filter removal laser sheath—CavaClear—to remove an IVC filter when previous methods of removal have failed.

Philips CavaClear IVC filter removal laser sheath is the first and only FDA-cleared solution for advanced IVC filter removal, the company said in a press release. Earlier in 2021, the FDA granted the device Breakthrough Device Designation. Laser has been clinically proven to provide a success rate over 99%, with low complication rates, the press release adds.

IVC filters are used to treat patients with venous thromboembolism, in which blood clots form in the deep veins of the leg and groin, and can travel through the circulatory system. They are placed in the inferior vena cava to capture blood clots from moving to the lungs.

Research has shown that IVC filters may have long-term complications, as the filters can fracture and travel through the bloodstream to other parts of the body. Other identified long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. The FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated.

Prior to CavaClear, limited options for removal existed if the filter became difficult to remove, according to Philips. Advanced retrieval tools and techniques are required if the IVC filter becomes embedded in the vasculature. Physicians previously had very few tools to remove the filter when complications occurred and until now there were no FDA-approved devices for this type of advanced removal.

“Today is a historic day. With the approval of CavaClear, physicians now have a device specifically geared remove chronically embedded IVC filters,” said Kush R Desai MD, associate professor of Radiology, Surgery, and Medicine, and director of deep venous interventions at Northwestern University Feinberg School of Medicine (Chicago, USA). “Backed by evidence, this technology can be applied to retrieve IVC filters that are no longer indicated, reducing potential clinical risk for patients and satisfying the FDA’s guidance to retrieve filters when they are no longer indicated.”

“With the FDA’s clearance of CavaClear more than one million patients and their physicians now have access to a safe, effective and efficient option for advanced IVC filter removal,” said Chris Landon, senior vice president and General Manager Image Guided Therapy Devices at Philips. “This clearance demonstrates the commitment of Philips to innovating procedures with physician collaboration to meet unmet needs that can have a critical impact on the lives of patients and their families.”

Cardiovascular Systems has initiated a voluntary recall of unused Wirion embolic protection systems  due to complaints of filter breakage during retrieval.

Wirion is a distal embolic protection filter used to capture thrombus and debris that can be associated with all types of peripheral vascular intervention procedures, including atherectomy.

CSI has informed all affected healthcare facilities to discontinue use of Wirion immediately and return unused product to CSI. The US Food and Drug Administration (FDA) has also been notified. To date, CSI has received nine complaints of filter breakage during retrieval. Filter breakage may result in device embolism and possible additional intervention.

The company plans to voluntarily recall all Wirion units currently in customer inventory. In total, 697 devices were distributed in the USA between 22 March and 15 November 2021.

XACT Robotics has announced plans to present oral and virtual presentations at the Radiology Society of North America (RSNA 2021, 28 November–2 December, Chicago, USA and virtual) that showcase clinical findings and case studies from leading radiology centres.

Sebastian Flacke (Lahey Hospital and Medical Center, Burlington, USA) will present new data from a multicentre study using the XACT ACE robotic system during percutaneous procedures. His presentation, “Feasibility and accuracy of a hands-free robotic system for CT [computed tomography]-guided percutaneous needle insertion and steering,” will be held on 29 November at 3pm CST.

In a second poster presentation, Gerald Grubbs (Sarasota Interventional Radiology (SIR), Sarasota, USA) will highlight recent clinical experience with the XACT ACE robotic system. His presentation, “Real world use of a hands-free robotic system for percutaneous procedures,” will be held virtually. On-demand access can be obtained by registering through the virtual meeting with RSNA.

RSNA 2021 will also serve as the venue where, for the first time, the company will introduce ACE Xtend, which enables remote activation of the XACT ACE robotic system for CT-guided percutaneous procedures. According to a press release from XACT Robotics, the system’s new capabilities will allow providers to enable precise robotic insertion and non-linear steering of various instruments from outside the procedure room. This, the company claims, will make the procedure more efficient and improve overall safety by reducing the risk of exposure to radiation and other harmful pathogens. 

The XACT ACE robotic system features non-linear steering to combine advanced image-based planning and real-time, the company said.

The system received US Food and Drug Administration (FDA) clearance for use during CT-guided percutaneous procedures, as well as CE mark, and commenced commercialisation in October 2020.

The company will showcase the XACT ACE robotic system, including its new ACE Xtend, at the booth (#1557) throughout the RSNA meeting, and at a virtual product theatre on Monday 29 November at 4pm CST.

Medtronic has announced its ambition to achieve net zero carbon emissions by fiscal year 2045 across its operations and value chain to accelerate efforts to combat climate change. The announcement comes amidst the 2021 United Nations Climate Change Conference (COP 26), where world leaders are focusing on collectively cutting greenhouse gas (GHG) emissions and limiting global warming to 1.5 degrees Celsius compared to pre-industrial levels.

As published in Medtronic’s new Decarbonization Roadmap, the FY45 milestone builds on the company’s existing goal of reaching carbon neutrality in its operations by fiscal year 2030, to encompass GHG emissions reductions across its entire value chain. To achieve its ambition, Medtronic will pursue setting GHG emission reduction targets across scopes 1, 2, and 3 through the Science-Based Targets Initiative (SBTi) – a multi-year initiative that provides companies a clearly defined path to reduce emissions aligned with the Paris Agreement.

“As a global healthcare technology leader, our goal is to transform industry expectations and behaviour where health and climate change intersect,” said Geoff Martha, Medtronic chairman and chief executive officer. “Our teams across 150 countries are actively working to protect our planet by reducing our energy use, investing in renewables, and now moving toward net zero emissions throughout our operations, supply chain and logistic partners, by pursuing science-based targets.”

Randomised placebo-controlled trials show consistently that renal denervation provides significant reduction in ambulatory and office blood pressure, the findings of a systematic review and meta-analysis suggest.

Findings of the paper, authored by Yousif Ahmad (Yale School of Medicine, Yale University, New Haven) and colleagues, were published in JACC: Cardiovascular Interventions and presented during an oral abstract session at the Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando USA and virtual).

In their paper, Ahmad and colleagues note that renal denervation has undergone several blinded placebo-controlled trials, covering the spectrum from patients with drug-resistant hypertension to those not yet taking antihypertensive medication.

The authors performed an updated meta-analysis of randomised placebo-controlled trials of renal denervation and specifically compared the effect of renal denervation in patients taking medications and in those not taking medications. This included latest evidence from the RADIANCE-HTN TRIO trial, presented on the same day at TCT 2021 in a late-breaking trial session.

The study’s primary efficacy outcome was the change in ambulatory systolic blood pressure beyond the effect of the placebo procedure, and analysis was stratified by whether there was background antihypertensive medication use.

Ahmad and colleagues report that there were seven eligible trials, totalling 1,368 patients.

Outlining the results, the study team notes that renal denervation significantly reduced ambulatory systolic (mean difference −3.61mmHg; 95% confidence interval [CI]: -4.89 to -2.33mmHg; p<0.0001), ambulatory diastolic (-1.85mmHg; 95% CI: -2.78 to -0.92mmHg; p<0.0001), office systolic (-5.86mmHg; 95% CI: -7.77 to -3.94mmHg; p<0.0001), and office diastolic (-3.63 mm Hg; 95% CI: -4.77 to -2.50; P < 0.0001) blood pressure.

There was no evidence that the use of concomitant antihypertensive medication had a significant impact on the effect of denervation on any of these endpoints (p-interaction=NS for each comparison).

Ahmad and colleagues conclude that the randomised placebo-controlled trials show “consistently” that renal denervation provides significant reduction in ambulatory and office blood pressure.

“Although the magnitude of benefit, about 4/2mmHg, is modest, it is similar between patients on background antihypertensive medications and those who are not. Denervation could therefore be a useful strategy at various points for patients who are not willing to add antihypertensive agents,” the study’s authors note. “Whether the effect changes with time is currently unknown.”