BioStable Science & Engineering out of Austin, Texas won FDA clearance for its HAART 200 aortic annuloplasty device indicated for repair of congenital bicuspid aortic valve in patients with aortic valve insufficiency. A similar device, the HAART 300 for people with all three aortic valve leaflets, was cleared by the FDA earlier this y (Read more...)
Tag Archive for Cardiac Surgery
Injectable Tissue Patch to Fix Broken Hearts
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Scientists at the University of Toronto have developed a bandage-like patch that can be delivered into the heart through a needle, in combination with stem cells allowing for minimally invasive cardiac tissue repair, currently an impossible task. After a massive heart attack, myocardial tissue damage can significantly reduce the cardiac output. One (Read more...)
Medtronics New Avalus Pericardial Aortic Surgical Valve Approved in U.S. and Europe
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Medtronic today announced FDA approval and European CE marking of the company’s Avalus pericardial aortic surgical valve. The device is currently the only stented surgical aortic valve that does not limit patients’ ability to undergo MRI scans, and whole body scans are allowed as there are absolutely no restrictions and no rel (Read more...)
Medtronic CoreValve Evolut PRO TAVR Valve Cleared in Europe
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Medtronic won the European CE Mark and is introducing its CoreValve Evolut PRO transcatheter aortic valve in Europe for patients with severe aortic stenosis who are considered at intermediate, high, or extreme risk of not doing well from an open heart surgery. The Evolut PRO features an external porcine pericardial tissue wrap that helps (Read more...)
Medtronic’s CoreValve Evolut Transcatheter Aortic Valves Now Approved for Intermediate Risk Patients
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Medtronic has announced that its CoreValve Evolut transcatheter aortic valve replacement platform, consisting of CoreValve, CoreValve Evolut R, CoreValve Evolut PRO, is now FDA approved for patients with “symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.” Previously, the products were o (Read more...)
Edwards INSPIRIS RESILIA Aortic Valve Now Approved in U.S.A.
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Edwards Lifesciences has announced that the FDA has issued approval for its INSPIRIS RESILIA prosthetic aortic valve, which is based on the popular Carpentier-Edwards PERIMOUNT device. Cleared in Europe just under a year ago, the INSPIRIS RESILIA features flaps made from RESILIA material, a tissue developed by Edwards that helps maintain the i (Read more...)
3D Printed Patient Cardiovascular Anatomy to Guide Replacement Heart Valves
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In cases of heart valve replacements, surgeons have different sizes and options to choose from, each prosthetic device having its unique qualities and limitations. Predicting the best replacement heart valve for patient’s specific morphology may soon be easier to figure out thanks to the use of 3D printing. Researchers at Georgia Tech are pri (Read more...)
Calon Cardio’s MiniVAD Left Ventricluar Assist Device Set for 2018 Clinical Trials
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Working with the University of Swansea, Calon Cardio, a Welsh firm, has created the first UK-developed Left Ventricluar Assist Device (LVAD). The MiniVAD is scheduled to begin a 50 patient clinical trial in late 2018, with a full clinical rollout planned for 2020. Calon Cardio’s miniature implantable heart pump is used to treat advanced (Read more...)
Pulsed High Intensity Ultrasound Removes Calcified Buildup from Prosthetic Heart Valves
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Prosthetic heart valves that fit inside failed natural valves have now been used for years to treat thousands of patients. As time passes following implantation, the man-made valves tend to accumulate calcified debris over their leaflets. This slowly degrades their functionality and eventually requires revision procedures that may involve repl (Read more...)
Third Pole’s On-Demand Portable iNO: Interview with Dr. Warren Zapol
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Inhaled nitric oxide (iNO) relaxes blood vessels in the lungs and is an important and life-saving treatment for pulmonary hypertension. Current iNO delivery solutions are estimated to cost $2,800 per day and rely on compressed gas delivery which limits accessibility and applicability of this technology worldwide. Dr. Warren Zapol and team, led (Read more...)
Edwards SAPIEN 3 Cardiac Valve FDA Approved for Mitral and Aortic Valve-in-Valve Procedures
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Edwards Lifesciences received FDA approval for its SAPIEN 3 transcatheter prosthetic heart valve to be used for valve-in-valve procedures. Indicated for placement within both the aortic and mitral valves in patients at risk of undergoing open heart surgery to remove an existing valve, the SAPIEN 3 can reside within a previously implanted biopr (Read more...)
Sentinel Cerebral Protection System for Preventing Strokes During Transcatheter Valve Repairs Cleared by FDA
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While transcatheter aortic valve repair (TAVR) procedures can help avoid open heart surgeries in many fragile patients, there is a substantial risk that embolic debris is released from the calcified valves. The brain is particularly in danger, as the dislodged material can block blood vessels feeding it and result in strokes. Claret Medic (Read more...)
3D Printed Pediatric Stents That Grow With Patient’s Vessels
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Sadly, it is not only old people that receive cardiac stent implants. Often young children with certain cardiovascular conditions can benefit significantly from stent implantations and conduits, but because vasculature grows along with the rest of the body, the stents’ benefits can be short lived and not fully realized. Now researchers at&nbs (Read more...)
PREVENA DUO Negative Pressure Wound Therapy Treats Two Incisions at Same Time
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Acelity, based in San Antonio, Texas, is releasing the PREVENA DUO Incision Management System, a disposable negative pressure wound therapy (NPWT) system that can be used to manage two surgical incisions at the same time. The company expects the PREVENA DUO to be used post vascular harvesting, breast reconstruction, and ortho trauma procedures (Read more...)
Abiomed Unveils 3rd Generation Impella CP Heart Pump for PCI and Cardiogenic Shock
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Abiomed, the maker of implantable cardiac assistive devices, has just announced its new 3rd generation Impella CP heart pump. The device is designed to assist the native heart during percutaneous coronary interventional (PCI) procedures that can be difficult to tolerate for fragile patients, as well as to stabilize those post cardiac infarct t (Read more...)
Edwards HemoSphere Hemodynamic Monitoring System Cleared by FDA
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Edwards Lifesciences won FDA clearance for its HemoSphere hemodynamics monitoring system. It works with the Swan-Ganz pulmonary artery catheters that can provide flow, pressure and global indicator of oxygen saturation (CCO, RVEF, RVEDV, SVO2), and the Edwards oximetry central venous catheter that in addition to those can continuously monitor& (Read more...)
HAART 300 Aortic Annuloplasty Device Cleared by FDA to Repair Aortic Valves
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BioStable Science & Engineering, a company based in Austin, Texas, won FDA clearance for its HAART 300 Aortic Annuloplasty Device. Having received the CE Mark clearance last year, the company has already begun distributing the device in a few specialty European centers. According to the firm, this is the first annuloplasty device for repai (Read more...)
Heart Sleeve Helps Heart Pump Blood: Interview with Harvard’s Ellen Roche
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Heart failure is a very common clinical condition, afflicting millions of patients worldwide, and its prevalence is expected to further increase in the near future. Unfortunately, there are limited treatment options for advanced heart failure and the overall prognosis remains poor. Heart transplantation is considered to be the only definitive cure, (Read more...)
Medtronic’s New CoreValve Evolut Pro Transcatheter Aortic Valve Approved in U.S.
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Medtronic received FDA approval for its CoreValve Evolut Pro transcatheter valve for implantation into symptomatic patients with severe aortic stenosis who are too fragile for open heart surgery. The self-expanding valve is based on the CoreValve Evolut R, and has a porcine pericardial tissue wrap that makes contact with the native valve and p (Read more...)
Spectranetics Bridge Occlusion Balloon Plugs Large Vessel Tears Caused by Lead Extractions
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Spectranetics, a Colorado Springs, CO firm, won FDA 510(k) clearance for its Bridge Occlusion Balloon, a device used to block large vessels, typically the superior vena cava (SVC), if a tear happens while removing cardiac leads. Though tears are rare, when they do happen the rapid blood loss can be difficult to manage. The Bridge Occlusion [&h (Read more...)