Clinical News Industry News

effectiveness and qualitative outcomes.

Analysis revealed that two patients (3.3%) developed early discharge after transradial stenting of coronary arteries Study (EASY) grade I/Bleeding Academic Research Consortium (BARC) type I haematomas at the device access site. As a measure of effectiveness, a haemodynamic effect was observed after each spike delivery in 54 patients (90%).

Pilot study of wire pacing sleeve yields positive results in TAVI and PCI procedures

A first-in-human trial using a purpose-built device to provide direct wire pacing without the need for a temporary venous pacemaker during transcatheter aortic valve implantation (TAVI) and complex percutaneous coronary intervention (PCI) has found that the device was safe and effective.

According to Electroducer, the company behind the Electroducer Sleeve, the device is an electroconductive device made of highly innovative material which is intended to transmit, in a safe way for the patient, the electrical signal from an external pacemaker to the heart through the guidewire.

Results of the first-in-man study were published in the journal EuroIntervention. Researchers from four French medical centres—the Clinique Pasteur in Toulouse, the Cardiovascular Institute in Grenoble, the Médipôle Lyon-Villeurbanne Hospital in Villeurbanne and the Jacques Cartier Private Hospital in Massy—enrolled 60 patients in the study, 39 underwent TAVI, and 21 underwent PCI.

The primary endpoint was an analysis of a safety outcome, defined as the occurrence of haematomas or bleeding complications at the device vascular access site. Secondary endpoints included analyses of

Conference calendar

25–28 February

Cardiovascular Research Technologies (CRT)

Washington DC, USA crtmeeting.org

4–6 March

American College of Cardiology (ACC)

2023 Scientific Session New Orleans, USA pcronline.com

16–18 March

Houston Aortic Symposium Houston, USA houstonaorticsymposium.com

Analyses of other secondary endpoints showed that two patients (6.3%) presented asymptomatic radial artery occlusion.

Jérôme Wintzer-Wekehind

(Cardiovascular Institute, Grenoble, France) principal investigator on the study, said: “As well as offering benefits for patients, this device is simple and universal—these advantages mean there will certainly be widespread uptake and usage.”

According to a press release from Electroducer, the Electroducer Sleeve is expected to reach the US market in 2023, followed by the European market in 2024, once it receives US Food and Drug Administration (FDA) authorisation and CE marking respectively.

DurAVR heart valve system gets green light from US FDA for early feasibility study

Anteris Technologies has announced that the US Food and Drug Administration (FDA) has conditionally approved its DurAVR transcatheter heart valve system for an investigational device exemption (IDE) application to commence an early feasibility study (EFS).

DurAVR is a balloon-expandable, 3D single-piece aortic valve, which is shaped to mimic the native human valve.

The EFS study will evaluate the safety and feasibility of the device in the treatment of subjects with symptomatic severe native aortic stenosis. The FDA concluded the company provided adequate data to support the initiation of a clinical study in the USA, Anteris Technologies said in a press release. The EFS will enrol 15 subjects at seven heart valve centres of excellence within the USA. It is anticipated the study will commence in early 2023, paving the way for a pivotal, registration aortic stenosis trial in the first half of 2024. confirmatory trial of the Corvia atrial shunt in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction.

The primary and key secondary endpoints of this trial include safety and device feasibility assessments such as success of implantation at the anatomically accurate position, and haemodynamic performance assessments including effective orifice area (EOA), mean gradient, aortic regurgitation, paravalvular leak (PVL) and Doppler Velocity Index (DVI). Patient outcomes such as stroke, myocardial infarction, life-threatening bleeds, and all-cause mortality are to be reported at 30 days, three months, and one-year post implantation.

The FDA has categorised DurAVR in this study as a Centers for Medicare & Medicaid Services (CMS) category B device, which permits the device to be sold during the study pending CMS approval.

“I am pleased and eager to begin the DurAVR transcatheter heart valve EFS to further evaluate this promising novel technology. The single piece, native-shape valve design of the DurAVR transcatheter heart valve represents an advancement to existing heart valve technologies. I am excited to see the potential of the DurAVR transcatheter heart valve in treating patients suffering from severe aortic stenosis,” stated Michael Reardon (Houston Methodist Hospital, Houston, USA), study chair for the DurAVR EFS.

The DurAVR THV System is limited for investigational use only.

The first patient was enrolled and randomised by interventional cardiologist Scott Lilly and heart failure cardiologist Rami Kahwash (both Ohio State University Wexner Medical Center, Columbus, USA).

RESPONDER-HF is a randomised, sham-controlled trial including up to 260 patients from 60 centres across the USA, Europe, and Australia. The trial will evaluate the efficacy of the Corvia Atrial Shunt to reduce HF hospitalisations and improve quality of life (QoL). Sanjiv Shah (Bluhm Cardiovascular Institute, Chicago, USA) and and Martin Leon (Columbia University Irving Medical Center, New York, USA) serve as lead investigators for the study.

The RESPONDER-HF confirmatory trial builds on scientific data and progressive learnings from REDUCE LAP-HF II, the largest randomised controlled trial of a device-based therapy for HFpEF patients. As published in Circulation, REDUCE LAP-HF II is the only study of an implantable therapeutic device to show clinical benefit in this population. Within the large responder group, representing 50% of study patients, treatment with the Corvia Atrial Shunt resulted in a 45% reduction in HF events and a 55% greater improvement in QoL compared to sham control.

20–22 March

Technology and Heart Failure Therapeutics (THT) Boston, USA tht2023.crfconnect.com

25–27 April

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

6–9 May

American Association for Thoracic Surgery (AATS) Annual Meeting Los Angeles, USA events.aats.org/am23

First

patient randomised in RESPONDER-HF trial of Corvia atrial shunt

Corvia Medical has announced that the first patient has been randomised in RESPONDER-HF, a global

“We are committed to demonstrating the potential benefit of atrial shunt therapy and anticipate RESPONDERHF will validate the REDUCE LAP-HF II responder group findings, which correspond to two-thirds of people with HFpEF, or 2 million people in the USA alone,” commented Leon. Shah further added: “The RESPONDER-HF trial will not only continue to advance our scientific understanding of shunting in HFpEF, but also has the potential to change the treatment paradigm, and in doing so, move us one step closer to precision medicine in heart failure.”

16–19 May

EuroPCR 2023 Paris, France pcronline.com

18–20 May

Society for Cardiovascular Angiography and Interventions (SCAI)

2023 Scientific Sessions Phoenix, USA scai.org/education-and-events

7–10 June

The Structural Heart Summit (TVT) Phoenix, USA tvt.crfconnect.com

25–28 August

European Society of Cardiology (ESC) Congress Amsterdam, The Netherlands escardio.org

4–7 October

European Association for CardioThoracic Surgery (EACTS) Annual Meeting

Vienna, Austria eacts.org/annual-meeting/

23–26 October

TCT 2023

San Francisco, USA tct2023.crfconnect.com