Industry News

Funding secured to advance development of Pulse IVL system

AVS has announced that it raised US$20 million in Series B financing, which the company says will accelerate clinical trial timelines for its device for peripheral application in pulsatile intravascular lithotripsy (PIVL) cases, and advance development and preclinical work on a PIVL device for coronary cases.

BioStar Capital, the lead investor in the company’s Series A round, also led the Series B round.

AVS’ novel balloon-based platform, the Pulse IVL system, shatters calcium with pressure waves in frequent bursts and expands calcified arteries, all with a single device.

In September 2022, AVS announced enrolment, successful treatment, and positive 30-day follow-up data of the first patients in its POWER PAD I clinical trial, a first-in-human study. Jon George (University of Pennsylvania Health System, Philadelphia, USA) an interventional cardiologist and medical advisor to AVS, assisted in trial cases in the Dominican Republic.

“Our early trial results showed that we can successfully treat patients with multiple lesions using a single device,” said George. “We saw patients report a reduction in leg pain, increase in blood flow to the leg, and improvement in their ability to walk in our initial study. This is a patient population that needs easier access to advanced therapies and this platform has the potential to provide that access.”

ReCor appoints Lara Barghout to lead commercialisation of Paradise renal denervation system

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.

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.

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

GE Healthcare announces agreement to acquire interventional guidance innovator Imactis

guidance across an array of care areas. Imactis is a France-based company that was founded in 2009 by Stéphane Lavallée and Lionel Carrat, who created CT-Navigation, an ergonomic universal solution that provides stereotactic needle guidance, enabling intuitive pre-planning and continuous control throughout a wide range of procedures, from diagnosis to treatment.

While this innovation currently focuses on CT, GE Healthcare plans to expand the technology to its imageguided therapy (IGT) business to drive further growth.

The Imactis CT-Navigation, which includes an integrated workstation, guidance software, and disposable procedure kit, is currently approved under the European Union’s Medical Devices Regulation (MDR) and has US Food and Drug Administration (FDA) clearance for use within the USA.

The completion of the transaction is subject to customary closing conditions, including review by the relevant governmental authorities in France. Financial details of the transaction have not been disclosed publicly.

Medtronic announces first enrolment in head-to-head randomised trial evaluating durability of EVAR

GORE Excluder AAA device family systems. The ADVANCE Trial is a global, postmarket, prospective, interventional, multicentre, randomised study that will enrol a minimum of 550 patients at up to 50 centres globally. Patients will be randomised to receive endovascular aneurysm repair (EVAR) with either the Endurant family or Excluder family grafts and will be followed at one month, one year, and annually through five years.

The first patient in the ADVANCE Trial was enrolled by the team led by Ray Workman at Novant Health Forsyth Medical Center (WinstonSalem, USA).

PRELUDE-BTK subanalysis suggests “advantage” of serration angioplasty Cagent Vascular has announced the results of a comparative subanalysis of the PRELUDE-below-the-knee (BTK) study versus plain balloon angioplasty. The study was led by Marianne Brodmann (Medical University of Graz, Graz, Austria).

Pulse IVL system

Conference calendar

4–9 March

Society of Interventional Radiology (SIR) 2023 Annual Scientific Meeting

Phoenix, USA sirmeeting.org

23–25 March

International Multidisciplinary Endovascular Forum

Florence, Italy imendoforum.com

16–19 April

European Conference on Interventional Oncology (ECIO) 2023

Stockholm, Sweden ecio.org/attend/ecio-2023

GE Healthcare announced it has entered into an agreement to acquire Imactis, an innovator in computed tomography (CT) interventional

25–27 April

Charing Cross (CX) Symposium 2023

London, UK cxsymposium.com

10–13 May

Venous Symposium 2023

New York, USA venous-symposium.com

18–21 May

Global Embolization Oncology Symposium Technologies (GEST) 2023 New York, USA annual.thegestgroup.com/GEST23

Medtronic has announced the first patient enrolment in the ADVANCE trial, a head-to-head randomised controlled trial of two leading aortic stent graft systems, the Medtronic Endurant II/IIs stent graft system and

This subanalysis compared their PRELUDE-BTK subset to a consecutive plain balloon angioplasty group. The Serranator-treated lesions had an average final residual stenosis of 17.2±8.2% vs. 33.7±15.7% in the plain balloon angioplasty group. This represents a 49% average improvement in final residual stenosis. In chronic total occlusions (CTO), there was a 62% improvement in final residual stenosis compared to the plain balloon angioplasty group. The average balloon inflation pressure was 5atm in the Serranator group vs. 9atm in the conventional balloon angioplasty group. Additionally, Serranator-treated arteries demonstrated 2.4 times greater calculated flow improvement vs. plain balloon angioplasty. These data, analysed by the same independent core lab, were recently published in the Journal of Endovascular Therapy Brodmann opined that “these results suggest an advantage for serration technology that should allow for superior wound healing and patient outcomes, while minimising the need for stent placement.”

1–3 June

International Conference on Complications in Interventional Radiology (ICCIR) 2023 Poertschach, Austria cirse.org/events/iccir

6–9 June

Leipzig Interventional Course (LINC) 2023

Leipzig, Germany leipzig-interventional-course.com

21–24 June

European Conference on Embolotherapy (ET) 2023

Valencia, Spain etconference.org/attend/et-2023

9–13 September

Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023

Copenhagen, Denmark cirsecongress.cirse.org

8–10 November

British Society of Interventional Radiology (BSIR) 2023

Newport, UK bsir.org/meetings/bsir-asm-2023