Clinical and Industry News

out the specifics behind the recall as well as the organisation’s advice on how to proceed for those affected.

Aortix pMCS pump provides “rapid” decongestion for patients with heart failure and renal impairment

Procyrion, a medical device company which aims to improve outcomes for patients with cardiac and renal impairment, has announced that use of its Aortix percutaneous mechanical circulatory support (pMCS) device led to rapid decongestion in a pilot study of patients admitted to the hospital with acute decompensated heart failure (ADHF) and worsening renal function, which is known as cardiorenal syndrome (CRS).

These patients, who were unresponsive to available medical therapy, demonstrated significant improvements in kidney function, cardiac function, and patient-reported assessment of shortness of breath at 30 days after treatment with the Aortix pump. The results from the CRS pilot study have been presented during the late-breaking clinical science session at the Technology and Heart Failure Therapeutics (THT) 2023 conference (20–22 March, Boston, USA).

Late-breaking data presented at THT showed substantial fluid loss and improvements in kidney and cardiac function at 30 days after Aortix pump therapy in patients admitted to the hospital with ADHF and worsening renal function.

“Patients admitted to the hospital with CRS are the most difficult to treat. They often have persistent congestion even after aggressive intravenous diuretic therapy, leading to very poor outcomes with high rates of mortality and rehospitalisation,” stated Jennifer A Cowger (Henry Ford Hospital, Detroit, USA). “After being unresponsive to available medical therapy for more than a week, patients who were treated with the Aortix pump showed a significant increase in urine output resulting in a large loss of excess fluid and improvements in kidney function present at 30 days, indicating the potential of the Aortix therapy to disrupt the harmful cycle of CRS.”

Medtronic recalls Mahurkar catheter due to “potential hub defect”

A catheter produced by Medtronic and used in haemodialysis has been recalled due to a defect that “may cause serious adverse health outcomes”.

An update on the US Food and Drug Administration (FDA) website has laid

The update describes a catheter hub defect in the Mahurkar acute dual lumen high-flow (13.5 French) haemodialysis catheter, which is also used for apheresis and infusion. It states that this may lead to “leaks across the catheters’ tubes”, which in the course of treatment could cause the mixing of arterial and venous blood, as well as “increased recirculation and poor dialysis” and even the development of clots in blood vessels. These complications could lead to the need for surgical removal of the catheter or bleeding. Medtronic advises that use of a faulty device could lead to “inadequate treatment, unintended radiation exposure, haemolysis, thrombus formation, embolism, delay to treatment, and potential infection”.

So far, there have been two reports of injuries related to the issue, though no reports of death. The release states that those receiving or administering care with the catheter may be affected, before it proceeds to cite a 7 December, 2022 letter from Medtronic for recommendations. For those with a device already in use, it says, clinicians should follow routine assessment procedures for “patency, function and efficacy” of the device, while also monitoring for movement of the catheter’s contents between its venous and arterial lumens. “It will not,” it is stressed, “present as an external leak or defect.” If the defect is detected, “clinical judgment” should be used to determine the “necessity and timing” of replacement.

Talaris Therapeutics announces restructuring and clinical trial discontinuations

Talaris Therapeutics has announced that it has completed a review of its business and programme prospects. Based on this review, Talaris has decided to discontinue its FREEDOM-1 and FREEDOM-2 clinical trials evaluating FCR001’s ability to induce durable tolerance in living donor kidney transplant recipients. This decision was primarily attributable to the pace of enrolment and the associated timeline to critical milestones. The company will continue to enrol its FREEDOM-3 Phase 2 clinical trial evaluating FCR001’s ability to induce tolerance in scleroderma.

The company has initiated a comprehensive review of strategic alternatives focused on maximising shareholder value, including possible business combinations and/or a divestiture of the company’s cell therapy chemistry, manufacturing and controls (CMC) capabilities. The company has not set a timetable for completion of this strategic review and does not intend to comment further on the status of this process unless or until its board of directors has approved a definitive course of action, or it is determined that other disclosure is appropriate. There can be no assurance that this strategic review will result in Talaris pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms.

In connection with the evaluation of strategic alternatives and in order to extend its resources, Talaris is implementing a restructuring plan that includes reducing its workforce by approximately one-third, with remaining employees primarily focused on maintaining the company’s cell therapy CMC capabilities and executing FREEDOM-3.

New anaemia options amid first US FDA approval for oral treatment

The US Food and Drug Administration (FDA) has approved Jesduvroq tablets (daprodustat, GlaxoSmithKline) as an oral treatment for anaemia caused by chronic kidney disease (CKD) for adults who have been receiving dialysis for at least four months. Jesduvroq is not approved for patients who are not on dialysis. Other FDA-approved treatments for this condition are injected into the blood or under the skin.

“With an oral drug option in addition to the FDA-approved injection options, adults with chronic kidney disease on dialysis now have multiple ways to treat their anaemia,” said Ann Farrell of the Center for Drug Evaluation and Research at the FDA. “This approval demonstrates the FDA’s commitment to helping bring a range of therapeutic options to patients with chronic diseases. Patients can consult with their healthcare providers to select the option that is most appropriate.”

Trial of histotripsy system for kidney tumours approved by US FDA

HistoSonics, the developer of a noninvasive platform and novel sonic beam therapy called histotripsy, has announced that the US Food and Drug Administration (FDA) has approved the company-sponsored #HOPE4KIDNEY trial, which is designed to evaluate the safety and technical success of the Edison system in targeting and destroying targeted primary renal tumours completely non-invasively, and without the need for incisions or needles. FDA approval of the #HOPE4KIDNEY investigational device exemption (IDE) trial comes after the company recently submitted results to the agency from its #HOPE4LIVER trials where the studies met both primary endpoints of safety and efficacy in destroying targeted liver tumours.

“We are very pleased with the FDA’s approval of our #HOPE4KIDNEY trial and appreciative of the agency’s prompt review process. This approval represents a substantial milestone for our company as we continue to expand histotripsy and its potential benefits into diseases that impact the lives of so many people,” commented Mike Blue, president and CEO of HistoSonics.

Blue added, “We are excited to expand on our experiences in successfully targeting and treating in the liver using our enhanced Edison platform that combines advanced imaging and targeting capabilities with real-time treatment monitoring. The kidney is a logical next application, as treating in the kidney has very similar procedural and anatomical considerations as the liver, and Edison was specifically designed to treat anywhere in the abdomen, as a starting point. In addition, the prevalence of kidney disease remains high with many patients kept in active surveillance or watchful waiting.”

Donor kidney preservation technology “may enable us to salvage more organs”

Transplant experts at Hackensack University Medical Center have been the first in the USA to use new kidney preservation technology that can expand the window of time in which a kidney is viable—reducing the time it takes to receive a kidney transplant.

Now the team is evaluating this approach to see if it extends the lives of donated organs, and whether it can thus expand the number of donor kidneys that are viable for transplantation, helping to address the organ shortage in the USA. The technology, known as the Kidney Assist device (XVIVO), works by keeping a donated kidney warm, functioning, and supplied with nutrients outside of the body prior to transplant. Doctors use the experimental device to supply blood and oxygen to a human kidney at normal body temperature.

Alio receives second US FDA clearance

Alio, the medical technology company behind the SmartPatch device for chronic disease, has announced its latest US Food and Drug Administration (FDA) clearance. The company’s second clearance added three additional metrics to its remote patient monitoring platform—haematocrit, haemoglobin and potassium.

The platform consists of a SmartPatch, hub, and portal, which noninvasively capture clinical-grade metrics for care teams. Alio makes it possible for patients and their care teams to monitor their condition on an ongoing basis by issuing actionable notifications. With this clearance, the SmartPatch is cleared for use in monitoring key metrics including skin temperature, auscultation, heart rate, haematocrit, haemoglobin, and potassium.

While the technology can be deployed to monitor a number of chronic conditions, the company’s first area of focus is patients with end-stage kidney disease (ESKD). Until now, there has been little-to-no advancement in care management or innovative solutions for patients on dialysis and their care teams, an Alio press release states. Patients with ESKD, it adds, are at particularly heightened risk for hospitalisations due to complications like fluid overload, dyskalemia, and more. The current standard of care only monitors key metrics through a monthly blood draw whereas the Alio SmartPatch painlessly takes readings every few hours.

Kidney Transplant Collaborative announces second phase of funding

The Kidney Transplant Collaborative (KTC) has received significant new funding that it says will “empower the organisation’s mission to reduce barriers in the transplant system with the ultimate goal of increasing the number of individuals able to receive a kidney transplant”. This new funding will enhance the KTC’s legislative efforts regarding living kidney donation and further support awarded grant projects that have achieved successful outcomes towards increasing kidney transplants.

A US national non-profit advocacy organisation, the KTC was founded in 2021 with the goal of reducing barriers for kidney patients, donors and families during the transplantation process. The KTC is funded by Ed and Penelope Peskowitz. Ed Peskowitz is a recipient of a kidney donation.

In February 2022, the KTC announced its inaugural grant recipients, who received funding for projects to improve the kidney transplantation process. This new funding will further support those projects that have shown potential in making a significant impact in increasing kidney transplants. The additional funding will provide the organisations with the ability to implement the projects regionally and nationally, saving more lives through kidney donations.

ASN and Home Dialysis University announce nephrology fellow education programme

The American Society of Nephrology (ASN) has announced a collaboration with the Home Dialysis University (HDU) to improve nephrology trainees’ knowledge, proficiency, and exposure to home dialysis therapies. Through this new collaboration, ASN will provide up to 30 scholarships for selected fellows to attend an in-person HDU fellows training course while, in partnership with HDU, ASN will launch a new 12-month virtual educational programme.

Home dialysis has been associated with lower cost and equal or better clinical outcomes than facility-based dialysis. It has been estimated that up to 85% of patients may be suitable to receive home dialysis. Yet, in 2019, only 12.6% of Medicare patients receiving dialysis underwent dialysis at home. Racial and ethnic minority populations have a disproportionately high risk of kidney failure. Despite this, minority populations are even less likely to be treated with home dialysis.

“Educating future nephrologists about home dialysis is foundational to ensuring all kidney failure patients have access to dialysis options that best fit their lives and needs”, said Michelle Josephson (University of Chicago, Chicago, USA), president of the ASN. “These are exciting times as ASN demonstrates its commitment to that effort by improving access to high quality home dialysis education for nephrology trainees. This collaboration between HDU and ASN represents a key initial step in that commitment.”

Enhanced ultrasound superior to MRI for diagnosing certain kidney tumours, study finds

Contrast-enhanced ultrasound (CEUS) is more accurate and reliable than magnetic resonance imaging (MRI) for examining certain kidney and liver nodules, according to two new studies published in the Journal of Ultrasound in Medicine (JUM) and highlighted by the International Contrast Ultrasound Society (ICUS).

An Ohio team reviewed clinical data over a 10-year period to assess the accuracy of CEUS diagnoses of benign kidney nodules in 341 patients. Their blinded analysis found that none of the CEUS diagnoses changed during that period.

“Our data confirm that when CEUS determines a kidney mass is benign, the mass is benign and no further follow up is needed—sparing the patient from unnecessary downstream tests, anxiety and costs,” according to Richard G Barr (Northeast Ohio Medical University, Rootstown, USA), the lead author of the kidney CEUS study.

“We also found that CEUS is a better and less expensive first-step evaluation for newly discovered liver nodules,” said Stephanie Wilson (University of Calgary, Calgary, Canada), principal investigator of the liver CEUS study. Wilson is also co-president of ICUS.

“CEUS found malignant or premalignant diagnoses that would likely have been missed or delayed if we had not used CEUS in these patients,” according to Wilson. This study shows that CEUS scans are at least equivalent if not superior to MRI for evaluating these liver lesions, and CEUS should be the first investigation for nodules found on surveillance for liver cancer, according to Wilson.

Interventional Systems announces endourology venture with surgical robot tech

Interventional Systems has announced a new venture—called LARC Robotics— aimed at using surgical robotics for percutaneous renal access.

Austria-based Interventional Systems said the unit simplifies percutaneous renal access in percutaneous nephrolithotomy (PCNL) procedures. This minimally invasive surgical technique helps to manage kidney stones.

The company said in a news release that Udo Nagele (Landeskrankenhaus Hall Hospital, Hall in Tirol, Austria) led the first surgeries at Landeskrankenhaus Hall. It plans to spend the coming months validating technical and clinical claims in both the USA and Europe. Interventional Systems launched this venture just two weeks after a personnel change in its C-suite. New CEO Pedro Costa said the company launched LARC Robotics “after understanding the market need”. Its robot simplifies gaining renal access as it allows for targeting under real-time fluoroscopy. LARC Robotics intends to offer it in combination with a digital platform for visualising patient-specific, high-fidelity, 3D reconstructions of diagnostic scans. The platform also features a data and analytics module for postprocedural analysis.

EU ministers approve changes to MDR transition timetable

The European Union’s Council of Ministers has today adopted a resolution to extend the deadline for the certification of medical devices under the Medical Devices Regulation (MDR). Producers of medical devices will have until 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices to meet the legal requirements.

The extension of the transition period will be granted under certain conditions, ensuring that only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time.

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. However, challenges in the implementation of the legislation led to concerns about a potential shortfall in the availability of certain devices, which prompted a rethink in the timetable for the regulation as proposed by the European Commission in December.

UK MHRA awarded £10 million to fast-track patient access to medical products

A total of £10 million has been awarded to the Medicines and Healthcare products Regulatory Agency (MHRA)— an executive agency of the UK Department of Health and Social Care (DHSC)—to help bring innovative new medicines and medical technologies to UK patients more quickly, His Majesty’s (HM) Treasury has announced.

The funding will be used to accelerate routes for bringing innovative medical products developed in the UK onto the market, as well as those made and approved by other trusted regulatory partners globally.

Over the next two years, the MHRA will use the money to support development of a thorough but shortened process to speed up the approval process for cutting-edge treatments developed in the UK with the greatest opportunity to meet the country’s healthcare priorities, such as cancer vaccines and artificial intelligence (AI)-based therapeutics for mental ill-health.

It will also support the establishment of an international recognition framework, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners, and provide patients with fasttrack access to best-in-class medical products that have been approved in other countries.

Medtronic, DaVita launch Mozarc Medical, a new company aimed at accelerating kidney care innovation

Medtronic and DaVita have announced the launch of Mozarc Medical—an independent new company that, they state in a press release, is “committed to reshaping kidney health and driving patient-centred technology solutions”.

“Mozarc Medical’s focus will be on meaningful and innovative kidney health technologies that improve the overall patient experience and increase access to care globally,” said Ven Manda, CEO of Mozarc Medical. “At a time when patient preferences are evolving and inhome kidney care is on the rise, Mozarc Medical is uniquely positioned to better serve patients with kidney disease around the world.”

Central to the creation of Mozarc Medical, the press release adds, is its global workforce, which includes the former Medtronic Renal Care Solutions (RCS) business (now part of Mozarc Medical) and “other industryleading talent hired to advance the new company’s strategic mission”. In addition to Manda, a 28-year veteran of Medtronic, the former RCS leadership team has also transitioned to serve as Mozarc Medical’s leadership team.

Xeltis secures funding to progress clinical trials

Xeltis has raised €32 million in a Series D2 equity fundraise, backed by a syndicate of current and new investors, which the company says will enable it to progress its clinical programmes into pivotal trials. Investors include Grand Pharma, DaVita Venture Group, EQT Life Sciences, Invest-NL and others.

Xeltis’ proprietary endogenous tissue restoration (ETR) platform, states a press release, utilises “an advanced polymer-based material which triggers the body’s natural healing response to regenerate the patient’s own tissue around it, forming new, living and longlasting vessels and valves”.

The company’s most advanced program, aXess, is a vascular access graft for patients with chronic kidney disease (CKD) requiring haemodialysis. Xeltis is also pursuing clinical programmes in pulmonary valve replacement and coronary artery bypass grafts.

Alongside the equity fundraise, Xeltis and Grand Pharma have completed a license deal, covering Greater China, for aXess and other potential haemodialysis products developed under the same technology platform. Under the agreement, Grand Pharma will have exclusive rights to develop, produce and commercialise these products in Greater China.

Conference Calendar

25–28 April

Charing Cross (CX) Symposium 2023 London, UK cxsymposium.com

26–29 April

13th International Congress of the Vascular Access Society (VAS) Porto, Portugal vas2023.com

19–21 May

Vascular Access Society of the Americas (VASA) Hands-On Practicum on Hemodialysis Access Houston, USA vasamd.org/events/2023-practicum

Meet our editorial board

Nicholas Inston

Chairman of the Editorial Board

Nicholas Inston is a transplant and vascular access surgeon, and the clinical service lead for renal surgery, at Queen Elizabeth Hospital in Birmingham, UK.

3–7 June

American Transplant Congress (ATC) San Diego, USA atcmeeting.org

5–7 June

UK Kidney Week (UKKW) Newport, UK ukkw.org

6–9 June

Leipzig Interventional Course (LINC) Leipzig, Germany leipzig-interventional-course.com

14–17 June

Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM23) National Harbor, USA vascular.org/vam-2023

15–18 June

60th European Renal Association (ERA) Congress Milan, Italy era-online.org/en/milan2023

23–24 June

Endo Vascular Access Meeting Patras, Greece evameeting.org

Ziv Haskal

Board Member

Ziv Haskal is a professor of radiology, and an interventional radiologist and interventional oncologist, at the University of Virginia School of Medicine in Charlottesville, USA.

Stephen Hohmann

Board Member

Stephen Hohmann is a vascular and general surgeon at the Texas Vascular Associates clinic in Dallas, USA.

Board Member

Robert Jones is an interventional radiologist at Queen Elizabeth Hospital in Birmingham, UK.