IceCure Medical, developer of the minimally-invasive ProSense System for cryoablation, which destroys tumours by freezing, today announced interim results from the ICESECRET study for the treatment of patients with small renal masses (SRM) who cannot be offered kidney-preserving surgery. Data were presented at the Urological Association Conference (14 December, Eilat, Israel). The presentation, titled “Renal Mass Cryoablation – Interim Analysis ICESECRET Study”, was delivered by Nasir Said (Bnai Zion Medical Center, Haifa, Israel).

According to the presentation, out of the 115 patients enrolled, 107 patients (112 lesions) returned for follow-up with a mean duration of 22.8 months and a range 12-60 months. In a subgroup of patients with no previous history of kidney cancer on the same kidney and a lesion ≤3cm, an 89.5% recurrence-free rate was observed at a mean follow-up time of 22.2 months when the procedure protocol was followed. 

The recurrence-free rate was 85.1% for the 107 patients (91 patients, including 13 patients who underwent a second cryoablation), at a mean follow-up period of 16.5 months. Five serious adverse events were reported, four of which were of mild severity and were treated conservatively and resolved within one to five days, with one severe complication of a new onset of ipsilateral hydronephrosis seven months after the cryoablation procedure that led to nephrectomy. 

Cryoablation time and hospitalisation time were relatively short, up to approximately 25 minutes and two days, respectively. The presentation concluded that, based on these interim results, cryoablation is safe and effective for treating renal masses under five centimetres. 

According to the American Journal of Roentgenology, small renal masses, which may be malignant or benign tumours in the kidney, have been rising in incidence over the past two decades. According to the American Cancer Society, in 2022, in the US, an estimated 79,000 new cases of kidney cancer will be diagnosed, with about 14,000 dying from the disease. Globally, there were more than 430,000 new cases of kidney cancer in 2020 and about 180,000 deaths according to World Cancer Research Fund International. 

“These impressive interim results demonstrate the value of ProSense for urologists and interventional radiologists as a therapeutic alternative when patients are not eligible for surgery,” stated IceCure’s Chief Executive Officer, Eyal Shamir. “We believe the findings will support further use of ProSense in the jurisdictions in which our cryoablation system is approved for use with benign and malignant tissues of the kidney. The growing body of data on ProSense’s efficacy and safety across a broad range of indications supports commercialization momentum, particularly in facilities that benefit from one device that can be used across multiple specialties.” 

ICESECRET, a prospective, multicentre, single-arm clinical trial is being performed at Bnai-Zion Medical Center, Haifa, Israel, and Shamir Medical Center, Zerifin, Israel, and led by principal investigator Halahmi Sarel (Bnai Zion Medical Center, Haifa, Israel). The trial included 115 patients (138 lesions) with localized SRM of ≤5cm who were treated with ProSense cryoablation under computed tomography (CT) guidance. Full engulfment of the renal lesion, including a safety margin of 0.5cm was achieved in approximately 96% of the procedures where there was no anatomical limitation. Follow-up visits are performed 6 weeks, 6 months, 1 year, and then annually up to 5 years after the procedure. During the follow-up visits, data related to local recurrence, based on CT imaging, is collected. Safety was determined by monitoring procedure-related adverse events throughout the study. 

ReCor Medical and its parent company Otsuka Medical Devices have announced the appointment of Lara Barghout as president and chief executive officer of ReCor.

Barghout will lead the ReCor business strategy and organisation in the global commercialisation of ReCor’s Paradise ultrasound renal denervation system for the treatment of hypertension. She brings more than 20 years of experience leading global businesses in the medical device industry, joining ReCor from Siemens Healthineers, where she was senior vice president and head of advanced therapies, leading the image guided therapy business in North America. Prior to Siemens Healthineers, Barghout held several roles at Terumo Cardiovascular.

“I am honoured to lead the extraordinary team at ReCor at an exciting time in the company’s growth,” said Barghout. “High blood pressure is a leading contributor to cardiovascular disease burden worldwide, resulting in increased patient risk and higher costs to health systems. I look forward to leading our focus to advance ultrasound renal denervation as a treatment for hypertension and the global commercialisation of the Paradise ultrasound renal denervation system. We believe our Paradise ultrasound renal denervation technology to be a true game changer in improving hypertension therapy, with the potential to offer a new option for physicians to help improve blood pressure outcomes for their patients on a global scale.”

Barghout succeeds Andrew Weiss, who joined ReCor in 2013 and led ReCor in the development of the Paradise system from its early clinical trials, to the acquisition of ReCor by Otsuka in 2018, through the RADIANCE trial successes and the recent submission to the US Food and Drug Administration (FDA) for premarket approval.

“We are delighted to name Ms Barghout President and CEO of ReCor. She is a highly experienced leader with a track record of commercial success across a range of medical device businesses, coupled with extensive experience in global leadership,” said Noriko Tojo, executive director of Otsuka Holdings and president of Otsuka Medical Devices. “We are very excited for Ms Barghout to lead ReCor into its next phase of global growth. Her deep commercial experience and adept leadership make her ideal to build on the technology development and clinical trial successes of the ReCor team, guiding the business to realise its therapeutic and commercial potential. I would like to thank Andy for his outstanding leadership and countless contributions over the past 10 years.”

The Paradise system bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the USA and Japan.

Europe’s health commissioner, Stella Kyriakides, has announced that proposals to extend the transition period for the implementation of the European Union’s (EU) Medical Device Regulation (MDR) will be put forward in early 2023. 

Kyriakides informed health ministers from the EU’s 27 member states of the plan at a meeting of the Employment, Social Policy, Health and Consumer Affairs Council in Brussels on Friday (9 December), where the council members discussed the current status of the implementation of the MDR.  

The regulation—which changes the way that medical devices are certified for use in the European market—first came into effect in 2021 with an initial three-year transition period, having been delayed by one year in 2020 due to the onset of the COVID-19 pandemic.  

Concerns have been raised over the impact of the transition to the new regulatory regime, with the European Society of Cardiology (ESC) last week calling upon ministers to act to prevent a “shortfall of essential medical devices for cardiovascular patients”, which the Society warned could include diagnostic and ablation catheters and some stents. 

At Friday’s meeting, Kyriakides informed ministers that she will propose an extension to the transition period for the implementation of the MDR in early 2023—with the measure then to be voted upon by the European Council and Parliament. 

“Patients rightly expect to have safe and high-quality medical devices,” Kyriakides told journalists at a press conference that followed the council meeting, where she acknowledged it is now a “crucial time” for the transition to the new rules. 

“We have been following the progress achieved towards this goal very closely in the past months and, while the number of notified bodies have increased and actions have been taken to prepare manufacturers, this is not enough,” Kyriakides added. “In addition, we are now experiencing supply shortages on the global market. We are still feeling the impacts of the pandemic, and now also the Russian war in Ukraine, where several manufacturers of devices are located. This is creating additional complications.  

“This is why I announced today to ministers that we will propose to extend the transition period to mitigate any short-term risks. This targeted amendment will take into account the risk class of different devices and address the sell-off date. At the same time, we will work on medium- and long-term solutions to address the more structural issues that have arisen with the new rules. 

“Our citizens do not only expect medical devices to be safe, they also expect them to be available. We will do everything in our power to ensure that this transition does not create any disruptions.” 

Egg Medical, a medical device company commercialising technologies to reduce scatter radiation exposure during interventional angiographic procedures, has announced that it has achieved CE mark for the EggNest XR radiation protection system. The EggNest protects the entire interventional team in hospital X-ray labs (cardiac catheterisation, electrophysiology, interventional radiology, and operating rooms) from the harm of long-term exposure to scatter radiation.

“Occupational exposure of hospital staff to X-rays during medical procedures is an important workplace risk. Almost everyone in the interventional cardiology and radiology profession knows someone with a radiation-related illness. There have been minimal improvements in X-ray shielding over the past 30 years, leaving the medical teams working in these environments exposed to scatter radiation every day,” said Robert Wilson, Egg Medical CEO. “The EggNest platform addresses the problem of hospital personnel radiation exposure for everyone working in these environments by reducing scatter radiation by an average of 91 per cent.”

With the CE mark certification, Egg Medical will continue expansion into all markets recognising the CE mark.

“At Egg Medical, our belief is that everyone deserves protection, meaning the entire interventional team,” said Wilson. “With CE mark approval of the EggNest platform, we are bringing this protection to more interventional teams worldwide.”

Findings from a recent prospective study show promising safety and patient outcomes data for locally advanced and borderline resectable pancreatic cancer treatment using ablative stereotactic magnetic resonance imaging (MRI)-guided on-table adaptive radiation therapy, also known as SMART. Approximately 25% of the study’s participants were patients treated at the Henry Ford Pancreatic Cancer Center (HFPCC; Detroit, USA).

Titled “Stereotactic MRI-guided on-table adaptive radiation therapy (SMART) for locally advanced pancreatic cancer,” this study was the first phase II, prospective, international, multi-institutional study to deliver ablative doses of radiation to patients with pancreatic cancer.

“As a pioneering institution in the field of MRI-guided adaptive radiation therapy, Henry Ford Health is thrilled to have led this novel study, which was the largest international study of ablative radiation for pancreatic cancer in the world,” said Ben Movsas, Medical Director of Henry Ford Health Cancer and Chair of Radiation Oncology. “Henry Ford was first in the world to treat a patient using the MRIdian MRI-Guided Radiation Therapy system back in 2017. Since then, we have treated many cancer patients with MRI-guided radiation therapy.”

The primary endpoint outcomes from the study were presented at the 64th annual meeting of the American Society for Radiation Oncology (ASTRO; 23–26 October, San Antonio, USA) by Parag Parikh, the principal investigator of the study and Director of Gastrointestinal Radiation Oncology and MR-Guided Radiation Therapy at Henry Ford Cancer.

“In this study, 136 patients were treated with ablative MRIdian SMART at 13 international centres,” said Parikh. “The study’s primary outcome measured grade 3 or higher gastrointestinal toxicity, such as nausea, vomiting or abdominal pain, in the first 90 days after treatment. The study’s primary safety objective was met, with zero incidence of acute grade 3 or higher gastrointestinal toxicity definitively related to SMART treatment.”

Secondary measures of the study include overall survival, local control, distant progression-free survival, and changes in patient-reported quality of life, Parikh explained. While study patients are still early in the follow-up period, preliminary clinical outcomes data of one-year local control and distant progression-free survival were 82.9% and 50.6% respectively. One-year overall survival from diagnosis was 93.9%.

A new report from a joint taskforce of the American College of Radiology (ACR) and the Society of Interventional Radiology (SIR) recommends improved access to interventional radiologists in small and rural areas. The taskforce was formed to explore strategies for recruitment and retention of interventional radiologists in rural areas, which have the greatest challenges with access to interventional radiologic care.

“Interventional radiologists play a key role in improving patient health outcomes and creating healthier communities,” said Alan H. Matsumoto, vice chair of the ACR Board of Chancellors and a member of the joint taskforce. “The recommendations should be beneficial for practices in small and rural areas that hope to recruit interventional radiologists and provide the care patients deserve.”

“Access to an interventional radiologist’s care can be the difference between life and death.”

The taskforce focused on improving training opportunities, creating templates to help radiology practices and hospitals provide interventional radiology (IR) services in small and rural communities, and developing appropriate financial models to recruit interventional radiologists to these areas and retain their services.

“Access to an interventional radiologist’s care can be the difference between life and death, yet millions of Americans living in rural communities do not have access to the image-guided treatments interventional radiologists perform to literally save life and limb,” said SIR President Parag J. Patel, professor of radiology at the Medical College of Wisconsin (Milwaukee, USA). “Access to IR services improves the care offered within a hospital or health system. The recommendations outlined in this paper will help practices attract IR talent and expand IR services where they are often needed the most, eliminating IR deserts and improving patients’ access to the care they need.”

The report was published online in the Journal of the American College of Radiology (JACR).

ŌNŌCOR has announced in a company press release that the ŌNŌ endovascular retrieval system was used to remove a large central-line-associated thrombus from the right atrium in a teenage patient.

The team at Children’s Hospital Los Angeles (CHLA; Los Angeles, USA) led by Darren Berman, Director of Congenital Interventional Catheterisation with CHLA’s Heart Institute, percutaneously removed a large fibrotic thrombus from a 14-year-old patient using a combination of ŌNŌ, endovascular snares, and electrocautery.

“This procedure was inspired by the Seattle procedure recently performed at the University of Washington, and represents the first time that a large haemodynamically problematic thrombus was captured and removed non-surgically, and without fragmentation or distal embolization of particulate matter,” said Berman. “The ŌNŌ was key to securing the mobile mass and subsequently removing it from the vasculature atraumatically.”

Berman continued, “Intra-atrial thrombus formation associated with indwelling central lines is a common problem. Typically, the approach is to treat with anticoagulants in the hopes that the clot reabsorbs. When this doesn’t work, and the thrombus burden remains substantial, it represents an ongoing risk for pulmonary and systemic emboli.

“Our patient today is representative of a clinical dilemma that we often face. Up until this point, the only options that we had were ‘watchful waiting’ or open-heart surgery,” said Berman.

The ŌNŌ designed to receive, align, compress, and remove material (non-biologic and biologic) from the vascular system. ŌNŌ is intuitive to use and is compatible with commercially available vascular sheaths, endovascular snares and other graspers.

“We are delighted that ŌNŌ was able to help the team at Children’s Hospital Los Angeles,” said Mark Piper, CEO of ŌNŌCOR. “ŌNŌ was designed to help safely remove material from the vascular system, so it’s rewarding to hear that the patient in Los Angeles has done well and recovered nicely from this procedure.”

ReCor Medical and Otsuka Medical Devices have announced that the RADIANCE II US Food and Drug Administration (FDA) investigational device exemption (IDE) pivotal trial evaluating the Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at two months.

The RADIANCE II US FDA IDE pivotal trial is a randomised, sham-controlled clinical trial of the ReCor Paradise uRDN System for the treatment of patients with uncontrolled hypertension. 224 patients with mild-to-moderate uncontrolled hypertension, previously treated with up to two medications, were randomised while off medications at more than 60 study centres in eight countries.

“Despite the truly formidable challenges of conducting a complex clinical trial in the throes of the COVID-19 pandemic, we are thrilled to observe these positive results of RADIANCE II, especially in light of those we have previously reported from RADIANCE-HTN SOLO and TRIO,” said study principal investigators Ajay Kirtane (Columbia University, New York, USA) and Michel Azizi (Hôpital Européen Georges Pompidou, Paris, France). “We cannot adequately convey our thanks to the patients, coordinators, and study physicians for their collective efforts, and we very much look forward to being able to present and publish the complete study details in the near future.”

“We at Otsuka are very pleased with the positive outcome of the RADIANCE II study,” said Kazumichi Kobayashi, executive deputy president of Otsuka Medical Devices. “With three successful clinical trials of the Paradise uRDN system, we believe even more strongly that the Paradise system can become an important treatment option for patients and physicians struggling to control blood pressure.”

“ReCor is thrilled that the RADIANCE II trial met its primary efficacy endpoint. Following the positive SOLO and TRIO clinical trials, RADIANCE II adds to the evidence for the Paradise system as a potential future treatment for patients with uncontrolled hypertension,” said ReCor president and CEO, Andrew M Weiss. “We would like to express our gratitude to the principal investigators, steering committee and all investigators for their efforts throughout this important trial.”

RADIANCE II is the third and largest component of ReCor’s RADIANCE Global Program—randomised and sham-controlled studies evaluating the Paradise uRDN System in patients with hypertension. The first two studies in the series are the previously reported RADIANCE-HTN SOLO (conducted in patients with mild-to-moderate hypertension) and TRIO (conducted in those who remained hypertensive despite being on antihypertensive therapy). Both studies met their primary effectiveness endpoints.

About 6.5 million Americans over the age of 40 suffer from peripheral arterial disease (PAD). In the USA, Black adults in their 50s are at least twice as likely to suffer from PAD as their white counterparts, a disparity that continues to increase with age.  

In a new paper published in Circulation, researchers at the Richard A and Susan F Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center (BIDMC; Boston, USA) conducted a large, nationwide analysis of Medicare beneficiaries to document racial differences in revascularisation treatment for PAD, and outcomes for patients with PAD. The team found that Black adults underwent significantly more endovascular peripheral vascular interventions (PVI), were treated for more advanced disease and were also more likely to experience adverse outcomes following PVI procedures, including amputation and death.   

“Black race was significantly associated with worse one-year outcomes after revascularisations, after adjusting for age and sex,” said senior corresponding author Eric Secemsky, director of Vascular Intervention at BIDMC, as well as section head of Interventional Cardiology and Vascular Research at the Smith Center for Outcomes Research at BIDMC. “This link persisted after we adjusted for individual and regional socioeconomic factors. However, the association between Black race and worse outcomes was no longer apparent after we adjusted for comorbidities, suggesting that the well documented Black-white disparities in the prevalence of PAD risk factors, including hypertension, diabetes and end-stage renal disease, explain the disproportionate development of PAD among Black adults.”

The analysis included 215,320 patients who underwent the gold-standard revascularisation procedure—PVI—between 2016 and 2018. Black adults had a higher incidence of treatment, with 0.86 percent of Black Medicare beneficiaries undergoing the procedure, compared to 0.51 percent of white Medicare beneficiaries. What is more, a greater proportion of Black adults were treated for more severe arterial disease, while more white patients were treated for a milder form of PAD. Despite their relatively greater severity of disease, a lower percentage of Black adults were prescribed key cardiovascular medications.

“Structural racism perpetuates these health disparities,” said Secemsky, who is also an associate professor of Medicine at Harvard Medical School (Boston, USA). “One important way in which these systemic and structural factors lead to worse outcomes in Black patients is through comorbidities. This suggests a critical need for targeted, upstream intervention to reduce the disproportionate burden of PAD in the Black population.”   

Co-authors included Sahana Natesan, Rishi K Wadhera, Siyan Chen, Yang Song, and Robert W Yeh of the Smith Center at BIDMC; Michael R Jaff of Harvard Medical School; and Jay Giri and Howard Julien of the Perelman School of Medicine, University of Pennsylvania (Philadelphia, USA).