Medtronic has initiated the PERIGON (pericardial surgical aortic valve replacement) pivotal trial, a global, prospective clinical trial evaluating an investigational surgical aortic heart valve made from bovine pericardial tissue that is intended to replace a diseased, damaged or malfunctioning native or prosthetic aortic valve. The PERIGON trial will study up to 650 patients at up to 40 sites in Europe, the U.S. and Canada.
The European Society of Cardiology (ESC) annual congress is the largest cardiology meeting in the world and hosts over 30,000 cardiovascular medical professionals during the five day event. The ESC has now announced that future congresses will be held in Barcelona in 2017 and Munich in 2018.
Essential Medical has received CE mark approval for its new vascular closure device, X-Seal. X-Seal closes femoral arterial punctures made during cardiac catheterisation procedures such as angiograms, angioplasty, and stenting. X-Seal is designed to provide cath lab professionals with improved closure and haemostasis. The potential worldwide market for vascular closure products is approximately $1bn.
Medtronic has undertaken the international launch of its Resolute Onyx drug-eluting stent following the receipt of CE mark approval. The first live patient implant of the Resolute Onyx occurred during the XII International Course of Endovascular and Myocardial Therapy in Madrid, Spain.
STENTYS has entered into a five-year agreement with Micell Technologies to be the exclusive distributor of the MiStent coronary stent worldwide (excluding the United States, Canada, China, South Korea and Japan).
Norbert Frey (Universitätsklinikum Schleswig-Holstein, Campus Kiel Klinik für Kardiologie und Angiologie, Kiel, Germany) and others report—in Circulation: Cardiovascular Interventions—that an injectable bioresorbable scaffold (IK-5001; BioLineRx, Bellerophon Therapeutics), which is designed to prevent or reverse adverse left ventricular remodelling, could revolutionise treatment after a large myocardial infarction as they found the scaffold to be well tolerated in patients with a ST-segment elevation myocardial infarction (STEMI). They add that their results have prompted the initiation of a multicentre, randomised, controlled trial to confirm the safety and efficacy of the scaffold.
A 19-year-old woman was successfully implanted with the SynCardia temporary Total Artificial Heart and bridged to a donor heart transplant after cardiac surgeons used 3D virtual implantation to determine she was fit-eligible for the procedure, according to a case series in November’s The Journal of Heart and Lung Transplantation. The case series evaluated four other patients for virtual implantation with one other meeting virtual fit criteria despite failing standard criteria.
A multidisciplinary group of cardiac surgeons and interventional cardiologists, Heart Valve Voice, have launched a White Paper (Giving a voice to those with heart valve disease) to call for improved care of patients with structural heart disease in the UK. The group claim that the UK is “persistently lagging behind” the rest of Europe in the number of aortic valve replacements and transcatheter aortic valve implantation (TAVI) procedures it performs and state that at least 30% of patients with severe aortic stenosis are left untreated.
Claret Medical has announced that the first patient has been successfully treated in its SENTINEL trial, which is a US multicenter pivotal trial of its Sentinel cerebral protection system. The landmark trial is the first prospective, randomised, controlled, blinded trial in the US to evaluate the role of cerebral protection during transcatheter aortic valve implantation (TAVI).
At the 2014 Transcatheter Cardiovascular Therapeutics (TCT) meeting (13–17 September, Washington, USA), Osprey Medical introduced its enhanced contrast-monitoring technology. The enhanced system, called the Avert Plus, was selected by a team of independent cardiologists from a large list of new technology applicants to be presented at an Emerging Innovative Cardiovascular Technology session during the TCT meeting.
Materialise has listed its 3D-printed cardiovascular HeartPrint model as a medical device in the USA and EU markets. After years of 3D printing anatomical models for educational and research purposes, the company addressed the need for models that can assist with diagnosing, planning and practicing complex cardiovascular procedures. According to a company press release, this move strengthens the company’s position in the market and is a natural extension of its Mimics Innovation Suite of software for medical image processing, which has an existing 510(k) clearance and CE mark.
Data from a late-breaking trial (ADVANCE Direct Aortic) presented at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS; 11–15 October, Milan, Italy) indicate that the direct aortic approach with the CoreValve transcatheter aortic valve implantation (TAVI) system is safe and effective for aortic stenosis patients at who are not suitable for the transfemoral approach.
Interim results from the PROACT (Prospective randomised On-X anticoagulation clinical trial) study indicate that patients with the On-X Plus 1.5 aortic heart valve may be safely managed at lower INR rates with statistically significant reductions in bleeding events and no increase in thromboembolic events even in higher risk patients.
A new study of men and women who were already being treated for heart disease, published in the Journal of the American College of Cardiology, shows that men and women have different cardiovascular and psychological reactions to mental stress. It looked at 56 women and 254 men diagnosed with heart disease enrolled in a larger REMIT study of the impact of the medication escitalopram on heart disease induced by mental stress.
In an analysis of about 460 patients with failed bioprosthetic aortic valves who underwent transcatheter valve-in-valve implantation, overall survival at one year was 83 percent, with survival associated with surgical valve size and mechanism of failure, according to a study in JAMA.
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