BioTrace Medical has received FDA 510(k) clearance for its Tempo Lead, which a press release describes as an innovative temporary pacing lead that has been designed for use in procedures in which temporary pacing is indicated, including transcatheter aortic valve implantation (TAVI) and electrophysiology procedures.
Medtronic has announced the FDA approval and US launch of the CoreValve Evolut R 34mm valve—the largest sized transcatheter aortic valve implantation (TAVI) system available in the USA. The new Evolut R 34mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26mm to 30mm. This large valve segment is estimated to account for approximately 25–30% of the eligible global TAVI patient population. Previously, some of these patients were unable to receive a TAVI due to the larger size of their native diseased aortic valve.
Miracor Medical Systems has raised additional funding as part of its Series-C financing round. The recent closing was led by Peppermint VenturePartners (Peppermint), who invested via the Peppermint CBF-1 fund (Berlin, Germany) with existing investors also participating, bringing the total amount raised in Series-C to € 7 Million. The company seeks to complete Series-C with a further € 8 Million.
The latest image guidance solutions of Philips will be featured at Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC). The company, according to a press release, will showcase its continued commitment to addressing the needs of patients with the introduction of instant wave-free ratio (iFR) co-registration, which integrates iFR pullback data with the angiogram, and the third generation of HeartNavigator, live image guidance software for advanced structural heart disease procedures.
A new study, published in JAMA Cardiology, indicates that health status outcomes in patients who undergo cardiac rehabilitation after an acute myocardial infarction are not significantly better than those of patients who do not undergo cardiac rehabilitation. However, similar to previous studies, the study found that cardiac rehabilitation significantly reduces mortality.
Anna Franzone (Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland) and others report in the JACC: Cardiovascular Interventions that transcatheter aortic valve implantation (TAVI) is a technically feasible approach for managing patients with aortic regurgitation who are high risk for surgery. They add TAVI in this group of patients is associated with an “acceptable risk of early mortality”.
CeloNova BioSciences has provided details of its activities at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October—2 November, Washington, DC, USA). A press release reports that preliminary clinical data, including primary endpoint, from the COBRA PzF NanoCoated coronary stent development programme will be presented. Additionally, pre-clinical data comparing tissue response characteristics of the COBRA PzF NanoCoated Coronary Stent to leading polymer-based drug eluting stents will be presented in a poster session.
Boston Scientific has announced key data that will be presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC, USA). Notably, the Watchman left atrial appendage closure device data will be featured in a late-breaking clinical trial session on 2 November and will highlight the procedural safety of the device since it became commercially available in the USA last year.
Svelte Medical has received the CE mark for the Direct sirolimus-eluting coronary stent rapid-exchange (RX) system for treating coronary artery disease. The new stent employs Discreet drug coating, composed of the well-studied drug sirolimus and a natural, amino acid-based polyesteramide (PEA) bioresorbable drug carrier (proprietary to DSM Biomedical).
New data for St Jude Medical’s devices and technologies will be presented during late-breaking clinical trial presentations at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) symposium (29 October–2 November, Washington, DC, USA). At press release reports that throughout the congress, the company will also feature its latest cardiovascular innovations—including PressureWire X guidewire, structural heart solutions and the CardioMEMS heart failure system—that demonstrate its commitment to transforming the treatment of cardiovascular disease.
A study published in Circulation has not only found that patients who adhere to medical regimens after revascularisation have increased survival but also that adherence is a more powerful predictor of adverse event-free survival than the type of revascularisation procedure that a patient had.
The FDA has granted conditional approval to conduct an investigational device exemption (IDE) study of Jarvik Heart’s new miniature left ventricular assist device (LVAD) System. The study will compare the implanted, portable electrically-powered Jarvik 15mm LVAD system with the Berlin Heart Excor Pediatric System.
Vascular Solutions has received 510(k) clearance from the FDA for the Fluent inflation device for use during cardiovascular procedures to create, maintain, and monitor pressure in balloon catheters. A press release reports that the company received CE mark clearance for the device in August 2016 and that Fluent has already begun international clinical evaluations. It adds that Vascular Solutions expects to commence the commercial launch of Fluent in the USA and Europe during the fourth quarter.
Elixir Medical has announced that it will showcase the first live case demonstration by transmission in the USA of its Desolve NXT novolimus-eluting bioresorbable coronary scaffold system at 2016 Transcatheter Cardiovascular Technologies (TCT) meeting (29 October–2 November, Washington DC. USA). The live case is due to be broadcast on the 30 October and, also, an Elixir-sponsored satellite symposium is scheduled on the same day from 6pm to 8pm.
Corindus Vascular Robotics is to host a breakfast symposium entitled “Robotic Therapy—current Applications & Future Vision” on 31 October at 7.00am at the 2016 Transcatheter Cardiovascular Therapeutics meeting (TCT; 29 October–2 November, Washington, DC, USA). Chaired by Martin B Leon (Center for Interventional Vascular Therapy NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, USA), the symposium will review the available data for robotic therapy in the cath lab and other related topics.
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