… VasoStitch, a start-up medical technology company, announced today that it has successfully completed its first in vivo study of its percutaneous access-and-closure system for the nonsurgical deployment of large-diameter transcatheter therapeutic devices, such as Transcatheter Aortic Valve Implants (TAVI) and Endovascular Aneurysm Repair (EVAR) devices. The VasoStitch system is designed to reduce procedural complexity [...]
Tag Archives: arrhythmias
VasoStitch – Access-and-Closure System for Nonsurgical Deployment of Transcatheter Therapies
Wednesday, February 1, 2012
Filed in Ideas For Surgery News
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Also tagged 29mm and 31mm valves, absence of serious coexisting conditions, acquisition of Sadra Medical in January 2011, acquisition of Ventor Technologies in 2009, acroMIS, Acurate TA by Switzerland based Symetis, address the high risk of stroke associated with TAVR, adoption of austerity measures, adverse impact on technology, age-related disease, all-cause mortality for patients in the inoperable cohort, alternative option for treating patients with aortic stenosis, American College of Cardiology ACC, Aortic stenosis is an insidious disease, Approval for the 23mm valve is expected in the second half of fiscal 2012, approximately 300000 people worldwide, better quality of life compared with surgical valve replacement, bioprosthetic valve is inserted through a catheter, Boston Scientific Corporation’s BSX Lotus valve, Boston Scientific plans to launch Lotus in EMEA in the second half of 2013, both Medtronic and Edwards in the fray since 2007, calcium deposits on the aortic valve, Candidates in queue include Engager from Medtronic, cardiac anesthesiologists, cardiac arrest, cardiac imaging specialists, cardiac surgeons, cardiac surgeons believe that patients who need the transapical approach inherently belong to a higher risk category, cause the valve to narrow, Caveats for TAVR Procedures, CE Mark trial of the next-generation 18F valve from Direct Flow Medical was scheduled to begin in 2011, Centera valve a low profile repositionable self-expanding valve, Centers for Medicare & Medicaid Services (CMS), chest pain, choosing the right delivery method, commercialize medtech, comparing TAVI with standard therapy, competitive landscape is likely to change, CoreValve, cut throat competition, dealing with high risk complications, declining procedure volume, delivered through the 14F eSheath delivery system, devices approved for transapical procedures, devices are priced at a hefty premium to conventional surgical valves, diagnosed with severe aortic stenosis, direct aortic access, Dr Alain Cribier, echocardiographers, economic potential of this specialized, Edwards is in an advantageous position on the transapical side, Edwards Lifesciences EW, enrollment in the US pivotal study of CoreValve, Europe, European Market, Evolving TAVR Market, FDA approval for transfemoral, FDA has asked to include major stroke as a primary endpoint, FDA has hitherto approved TAVR only for senile aortic stenosis, first mover advantage in the US market, First-in-man, focus on emerging markets, force the players to increasingly compete on price, forced to look for other solutions, half of the patients succumb within a couple of years, Heart failure, heart works harder to pump enough blood through the smaller valve opening, high surgical risk, high-risk patients with severe aortic stenosis, implanted within the diseased native aortic valve, Implementation, innovation and state-of-the-art medical technology, interventional cardiologists, irregular heart rhythms, JenaValve and Acurate TA, JenaValve from Germany based JenaValve Technology, Johnson & Johnson JNJ and Abbott Laboratories ABT have stakes in Direct Flow, key opinion leader KOL, left ventricular dysfunction, less invasive treatment, many patients with age working against them, medical devices companies, Medtronic began a pivotal trial for the Engager system, Medtronic MDT, Medtronic’s CoreValve portfolio in Europe includes 26mm, meet the urgent need of patients unfit for open heart surgery, multicenter randomized clinical trial, myriad of complications, nascent technologies, National Coverage Analysis for TAVR, necessity of the procedures to be performed in specialized centers, new procedure, noninvasive and heart failure cardiologists, on the transfemoral side Medtronic’s CoreValve had a larger share before the introduction of Edwards’ Sapien XT, one-third are considered ineligible for open heart surgery, Open heart surgery, originally developed to be delivered through two approaches, outside the US OUS, overt risk of stroke, performed via the transfemoral approach, physicians may have to perform 30 cases before they attain the desired level of proficiency, physicians’ learning curve, players adopting the acquisition route, presence of multiple coexisting conditions, prevailing economic uncertainty, principle investigator, problems such as fainting, progressive, proper selection of patients, proper training of the physicians and staff is significant, providing expertise. early clinical evidence, recent launches of two TAVR systems, reduces symptoms and improves survival, reimbursement pressure, replacing the diseased valve, request from the Society of Thoracic Surgeons STS, restore the normal blood flow, restructuring initiatives, Sapien has a price tag of $30000, Sapien transcatheter heart valve THV in the US November 2011, Sapien XT Cohort B is expected in 2014, scheduled for completion in mid 2012, self-expanding platform, Senile aortic valve stenosis, severe symptomatic aortic stenosis, shortcomings of TAVR, St Jude Medical is targeting a limited launch of the Portico valve in Europe before the end of 2012, St Jude Medical’s STJ Portico valve, STACCATO performed in Denmark, stalemate in Europe, state-of-the-art procedure, subclavian through the subclavian artery located beneath the collar bone, surgery for replacement of the aortic valve, Surgical replacement of the aortic valve, targeting the TAVR market in Europe, Team work cardiologists, The Placement of Aortic Transcatheter Valves PARTNER trial, the standard of care, to be delivered through transapical approaches, transapical procedure unfavorable, transapical TAVI may be inferior to surgical aortic valve replacement SAVR in operable elderly patients, transapical via a small incision between the ribs, transcatheter aortic valve replacement TAVR, Transcatheter aortic-valve implantation TAVI, Transcatheter Cardiovascular Therapeutics TCT, transfemoral, transfemoral approach is considered as a first line therapy, transfemoral via the patient’s femoral artery, under development from the Sapien line include Sapien 3 a lower profile balloon expandable valve, unfavorable reimbursement decision from the CMS, unsuitable for this open surgery, US approval of Sapien for high-risk Cohort A patients, valve from Direct Flow Medical, via three access routes, weakens, widespread economic uncertainty, Widespread rollout of TAVR
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