Shockwave Medical has announced US$40m in funding, co-led by returning investor Sofinnova Partners and new investor Venrock, with the participation of RA Capital, Deerfield, Sectoral Asset Management, Ally Bridge Group, and two undisclosed large-cap strategic investors.
The FDA has announced it has approved Boston Scientific’s Promus Element Plus and Promus Premier everolimus-eluting, platinum chromium coronary stent system (monorail and over-the-wire) systems. The FDA reports that both systems share similarities with already approved stent systems.
Novartis has announced that the US Food and Drug Administration (FDA) has approved Entresto (sacubitril/valsartan) tablets, previously known as LCZ696, for the treatment of heart failure with reduced ejection fraction.
Admedus has announced positive long-term data from the CardioCel phase II clinical trial assessing the efficacy and safety of the company’s proprietary bio-scaffold which has been implanted to repair congenital heart disease defects.
A retrospective analysis, published in Heart, indicates that early discharge (within 72 hours) after transfemoral transcatheter aortic valve implantation (TAVI) in selected patients does not increase the risk of death at 30 days compared with later discharge (after three days). Given that length of hospital stay is a main contributory factor in the costs associated with TAVI, early discharge (when appropriate) may help to reduce costs.
In an accompanying editorial to the report of the RIBS IV (Restenosis intra-stent of drug-eluting stents: drug-eluting balloon vs. everolimus-eluting stent) study, published in the Journal of American College of Cardiology (JACC), Antonio Colombo (EMO-IV Centro Cuore Columbus, Milan, Italy) and others argue that, for the moment, a drug-eluting stent should be the default strategy for treating most drug-eluting stent restenosis lesions. However, they state there remains “unanswered questions” about the management of drug-eluting stent restenosis.
Antonio Miceli (Istituto Clinico Sant’Ambrogio, University and Research Hospitals, Gruppo Ospedaliero SanDonato, Milan, Italy) and others report in the European Journal of Cardio-Thoracic Surgery that surgical aortic valve replacement using the right anterior minithoracomy approach and a sutureless valve (Perceval, Sorin) is associated with a trend towards better postoperative outcomes than those with transcatheter aortic valve implantation (TAVI) using the Sapien device (Edwards Lifesciences).
The first implantation of Thoratec’s HeartMate 3 has been performed via mini-thoracotomy. The implant begins a European study to evaluate outcomes and complications using less invasive surgical placement through hemisternotomy and left thoracotomy techniques. The study will include ten cases performed at three European centres following one initial case to build experience at each centre, and will measure the outcomes specified in the HeartMate 3 CE mark trial after 30 days of follow-up.
Patients are experiencing significant delays in access to approved cardiovascular devices due to bureaucratic inefficiencies, a Devices White Paper from the Cardiovascular Round Table (CRT) has found. The CRT is an independent forum established by the European Society of Cardiology (ESC) and comprised of cardiologists and representatives of the pharmaceutical, device and equipment industries.
Miracor Medical Systems has appointed an international scientific advisory council consisting of leading clinicians to support the further clinical and technological progress of its PiCSO acute myocardial infarction impulse system. The board includes Gregg W Stone (professor of Medicine Columbia University Medical Center, Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital, New York, USA ; co-director of Medical Research and Education at the Cardiovascular Research Foundation in New York, USA).
Direct Flow Medical has named Isaac George, surgical director of transcatheter therapies for the Columbia Heart Valve Center at the Columbia University Medical Center, as co-principal investigator of the US SALUS pivotal trial studying the company’s Transcatheter Heart Valve System. George joins co-principal investigator Murat Tuzcu, vice chairman of the department of cardiology for the Cleveland Clinic, in leading the trial.
An article e-published in in Catheterization and Cardiovascular Intervention highlights the mechanical effect of orbital atherectomy and rotational atherectomy in treating heavily calcified coronary lesions.
The US Food and Drug Administration (FDA) has granted expanded indications for use of ClearFlow’s patented PleuraFlow Active Clearance Technology system. PleuraFlow is a patented medical device that prevents chest drains from occluding with clot, which can lead to retained blood around the heart and lungs.
Opsens has received 510(k) clearance from the FDA for its OptoWire and OptoMonitor; its products that have been developed to measure fractional flow reserve (FFR). Claude Belleville, Opsens’ vice president medical devices, welcomed the approval and said that the company was “committed to becoming the first choice for cardiologists by delivering new, innovative guidewire technologies to measure FFR and improve the clinical outcome of patients with coronary artery disease.”
Poor sleep is associated with increased risk of heart attack and stroke, according to results from the WHO MONICA study. The research was presented at EuroHeartCare 2015 (15–16 June, Dubrovnik, Croatia) by Valery Gafarov, professor of cardiology at the Russian Academy of Medical Sciences in Novosibirsk, Russia.
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