Clinical News

February, Washington DC, USA), have demonstrated a low in-scaffold late lumen loss (LLL) rate and a good safety profile with no scaffold thrombosis at six months.

OpSens has announced the successful completion of enrolment in the SAFE–TAVI clinical study, studying left ventricular rapid pacing using SavvyWire in transcatheter aortic valve implantation (TAVI), in Europe.

The study enrolled 120 patients with severe aortic valve stenosis and other conditions requiring a TAVI procedure in which left ventricular rapid pacing was considered necessary.

The SAFE-TAVI study was conducted in nine hospitals including eight centres across Spain and one in Canada, at Quebec Heart and Lung Institute—Laval University (IUCPQ). As the global principal investigator of the SAFE-TAVI study, Josep RodésCabau from IUCPQ oversaw and coordinated the principal investigators in their respective Spanish hospitals.

OpSens’ SavvyWire was used for left ventricular pacing to evaluate the potential benefits of eliminating the need for venous access, reducing procedure time, and avoiding potential complications associated with right ventricular pacing.

“We successfully used the SavvyWire in a large variety of anatomies, implanting valves from all major companies, including Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific,” said RodésCabau. “Left ventricular rapid pacing is necessary to restrict the range of motion of the heart muscle during TAVI for optimal valve placement. The rapid pacing feature is important in SavvyWire’s performance in addition to providing real-time, accurate haemodynamic measurement during the TAVI procedure.”

OpSens received Health Canada and US Food and Drug Administration (FDA) clearance for SavvyWire in 2022. The SAFE-TAVI clinical study is being conducted as part of OpSens CE mark clinical strategy for the commercialisation of SavvyWire BIOMAG-I study demonstrates low rate of in-scaffold late lumen loss at six months

Angiographic and clinical data from the BIOMAG-I clinical study, presented at the 2023 Cardiovascular Research Technologies (CRT) conference (25–28

Michael Haude (Rheinland Klinikum, Neuss, Germany), BIOMAG-I coordinating clinical investigator, presented the results of the study, a prospective singlearm study assessing the safety and clinical performance of the Dreams 3G (Biotronik) resorbable magnesium scaffold (RMS).

The trial showed a low proportion of malapposed struts after implantation, and at six months struts were no longer discernable. The intravascular imaging documented a preservation of the scaffold area with a low mean neointimal area.

Bioresorbable scaffolds have been developed to provide temporary mechanical support, while controlling neointimal proliferation over the vascular healing period and preventing long-term stent-related adverse events. Dreams 3G, Biotronik’s next-generation drug-eluting RMS, is comprised of a proprietary magnesium alloy and maintains a resorption time of 12 months, the company said in a press release. Compared to its predecessor Dreams 2G, it offers benefits such as reduced strut thickness and a higher radial strength, the press release adds.

“Dreams 3G did not only show a low in-scaffold late lumen loss rate, we could also see the preservation of the scaffold area with mostly wellembedded and resorbing scaffold struts,” said Haude. “This thirdgeneration scaffold is on the level of contemporary drug-eluting stents while providing the benefits of a resorbable scaffold.”

The prospective BIOMAG-I clinical trial assesses the angiographic, clinical and safety performance of Dreams 3G of 116 patients with de novo coronary artery lesions. Fourteen clinics in eight European countries are taking part in the BIOMAG-I clinical trial with 20% of the patients presented with nonST-elevation myocardial infarction (NSTEMI) and more than 75% with B2/C lesions.

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 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 long-lasting vessels and valves.

The company’s most advanced programme, 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.

Cardiovascular Systems has announced the complete enrolment of its 2,000-patient ECLIPSE coronary trial.

ECLIPSE is a prospective, multicentre, randomised clinical trial of approximately 2,000 patients with severely calcified coronary lesions in the USA. Half of the participants received orbital atherectomy prior to drug-eluting stent implantation, while the other half received conventional angioplasty, including specialty balloons, followed by drug-eluting stent (DES) implantation.

The trial is powered to demonstrate differences in the primary endpoints of post-procedural in-stent minimal crosssectional area (assessed by optical coherence tomography [OCT] imaging in a subset of approximately 400 patients), and in the clinical outcome of target vessel failure at one year.

MedAlliance has announced enrolment of over 1,000 patients in its SELUTION DeNovo coronary randomised study. Recruitment is now a third of the way towards the target of 3,326 patients. SELUTION DeNovo compares the treatment strategy using a novel sirolimus drug-eluting balloon (DEB), Selution, versus a limus drugeluting stent (DES).

SELUTION DeNovo involves up to 70 participating sites across 15 countries. Patients are randomised before any vessel preparation to reflect current medical practice and to reduce bias. The objectives of the study are to demonstrate non-inferiority at both one and five years, and superiority for target vessel failure (TVF) at five years.

Selution SLR consists of an angioplasty balloon coated with MicroReservoirs containing a mixture of biodegradable polymer and the antirestenotic drug sirolimus. The microreservoiris are intended to provide controlled and sustained release of the drug for over 90 days, similar to a DES, but without leaving behind a metal scaffold.

“This is a major milestone for the SELUTION DeNovo trial, as it is now the largest DEB study ever conducted,” said co-principal investigator Christian Spaulding (Paris Cité University, Paris, France). “The study is performed in a true all-comers population and is not just looking at small vessel artery disease. The results will have a major impact on clinical practice.”

Selution SLR was awarded a CE mark for the treatment of coronary artery disease in May 2020.

MedAlliance was the first drug-eluting balloon company to receive US Food and Drug Administration (FDA) breakthrough designation status. In addition to the below-the-knee (BTK) and superficial femoral artery (SFA) indications for which the company received FDA IDE approval in May and August 2022, MedAlliance received coronary in-stent restenosis (ISR) IDE approval in October 2022 and de novo coronary artery lesions approval on 6 January 2023.

Results from the CONFORMAL early feasibility study (EFS), evaluating the use of angiography compared to transoesophageal echocardiogram (TEE) for left atrial appendage (LAA) assessment have been presented at the 2023 Cardiovascular Research Technologies (CRT) conference (25–28 February, Washington DC, USA).

William Gray, co-director of the Lankenau Heart Institute and professor of medicine at Thomas Jefferson University (Philadelphia, USA) during the Left Atrial Appendage Closure Forum at CRT.

The CLAAS system is designed to seal the LAA in patients with nonvalvular AF to reduce the risk of stroke without the need for anticoagulants. Featuring a proprietary foam-based architecture, the implant addresses a wide spectrum of LAA anatomies with only two sizes.