Abiomed has expanded its FDA pre-market approval for Impella heart pump use in high-risk percutaneous coronary interventions (PCI) to include its Impella CP heart pump. A press release reports that the Impella heart pumps provide the “only minimally invasive treatment option with the unique ability to stabilise the patient’s haemodynamics and unload the left ventricle of the heart”, which it adds allows the muscle to rest and recover its native function.
4Tech has appointed Michael Ennen as president and chief executive officer, effective immediately. Ennen succeeds co-founder Carine Schorochoff, who will continue to serve 4Tech as an advisor and board observer.
Teleflex is to acquire Vascular Solutions in a transaction valued at approximately US$1 billion. Under the terms of the agreement, Teleflex will acquire all of the issued and outstanding shares of Vascular Solutions common stock for US$56 per share, in cash.
Cardiologists at The James Cook University Hospital (Middlesbrough, UK), after receiving £1.6 million in NHS funding, are to initiate a trial—the UK Mini Mitral trial—that compares traditional sternotomy with minimally invasive sternotomy in patients undergoing mitral valve repair. A press release reports that the study is the largest of its kind and that the research has the potential to benefit thousands of patients worldwide, who have mitral valve regurgitation.
The Leonhard Lang defibrillation electrode DF29N is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The FDA has identified this as a Class I recall, “the most serious type of recall”. Use of these devices “may cause serious injuries or death”.
Data from the interim analysis of the ongoing ORION-1 study, which is evaluating The Medicines Company’s investigational first-in-class PCSK9 synthesis inhibitor, confirm the significant and durable low density lipoprotein (LDL) cholesterol reduction with the drug that was demonstrated up to day 90 in the preceding Phase 1 study. Additionally, the PCSK9si was well tolerated and no material safety issue was observed in the Day 90 interim analysis of unblinded safety data.
Abbott and St. Jude Medical have announced an agreement in principle to sell certain products to Terumo Corporation.
Tryton Medical has announced that it will be sponsoring a clinical symposium and exhibiting at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC, USA). The symposium is entitled “Establishing the New Standard: Definitive Treatment for Complex Bifurcation Lesions,” will be held in Room 143B on 31 October from 6:30am to 8am.
St Jude Medical is to form a Cyber Security Medical Advisory Board (CSMAB) to advise the company as it, according to a press release, continues to advance cyber security standards in the medical device industry by working with experts and government agencies. The press release reports that creating the board ensures St Jude Medical receives direct feedback from leading physicians on patient management considerations. It adds that the company has an “ongoing commitment is to ensure our medical device ecosystem always puts patient safety at the forefront”.
According to a study published in JACC: Cardiovascular Interventions, patients undergoing left main coronary artery percutaneous coronary intervention (PCI) had better outcomes when the procedure was performed by experienced, high-volume operators—even though the patients treated by the experienced operators tended to have more complex and extensive heart disease.
Lauren Sinnenberg (@lsinnie Penn Medicine Social Media and Health Innovation Lab, University of Pennsylvania, Philadelphia, USA) and others report in JAMA Cardiology that Twitter may be a useful tool for studying public communications about cardiovascular disease. They found that through the social networking site, they were able to identify 550,338 US-based tweets (of a sample of 10 billion) that were about cardiovascular disease and found that common topics discussed were risk factors, awareness, and management.
A new study indicates that patients with mild-to-moderate chronic kidney disease do not have worse outcomes after undergoing percutaneous coronary intervention (PCI) with a second-generation drug-eluting stent than patients with preserved renal function. Studies of PCI with a first-generation drug-eluting stent indicated that patients with any level of renal impairment had worse outcomes after PCI.
Samir B Pancholy (The Wright Center for Graduate Medical Education, The Commonwealth Medical College, Scranton, USA) and others report in JACC: Cardiovascular Interventions that prophylactic ipsilateral ulnar compression, during radial artery haemostasis, significantly reduces the risk of radial artery occlusion after transradial access. According to the authors, the “simplicity and the safety” of the manoeuver should encourage most radial operators and staff to “embrace the technique as default protocol”.
BioStable Science & Engineering has completed a direct de novo application to the FDA for Class II designation of its HAART 300 aortic annuloplasty device. A press releases states that the submission of the de novo request is an important milestone in BioStable’s efforts to bring the potential benefits of valve repair to US patients with aortic valve insufficiency.
St Jude Medical has announced the FDA clearance and launch of its PressureWire X guidewire fractional flow reserve (FFR) measurement system. According to a press release, the latest generation of the PressureWire guidewire system is designed to offer improved “shapeability” and better shape retention with the aim of reducing vessel trauma. The press release notes that the guidewire provides the accuracy and simplicity that physicians require when treating patients during percutaneous coronary intervention (PCI), especially those with complex anatomies.
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