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Condition: Heart Valve Disease
Procedure: Heart Valve Surgery
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Total 376 results found since Jan 2013.
Real-world experience using the ACURATE neo ™ prosthesis: 30-day outcomes of 1000 patients enrolled in the SAVI-TF registry.
CONCLUSIONS: In this initial experience, treatment with the ACURATE neoTM prosthesis resulted in excellent clinical outcomes with very low complication rates.
PMID: 29131801 [PubMed - as supplied by publisher]
Source: EuroIntervention - November 15, 2017 Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research
TCT 2017: Medtronic touts results from 6-month Evolut Pro study
Medtronic (NYSE:MDT) today released six-month data from a study of its Evolut Pro transcatheter aortic valve replacement platform, touting low rates of paravalvular leaks and low rates of all-cause mortality and disabling stroke.
Data came from 60 patients in the trial who received the Evolut Pro valve, and follow previously released 30-day outcomes.
Results at six-months indicated trace or no paravalvular leaks in 88% of patients, with low rates of all-cause mortality and disabling stroke. No instances of coronary obstruction or valve thrombosis were reported and the permanent pacemaker implantation rate was 11.7%, Medt...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news
TCT 2017: Medtronic touts 1-year intermediate data for Evolut R TAVR
Medtronic (NYSE:MDT) is touting data from a pair of studies of intermediate-risk patients implanted with its Evolut R replacement heart valve, presented today at the Transcatheter Cardiovascular Therapeutics annual meeting in Denver.
Fridley, Minn.-based Medtronic presented results from its Surtavi trial and Evolut R Forward real-world study of its next-generation transcatheter aortic valve replacement today at TCT.
One-year data from Surtavi, comparing the Evolut R and CoreValve devices with open heart surgery, showed a 7.8% mortality rate for the TAVR arm, compared with 8.5% for the open surgery arm. A sub-group analysi...
Source: Mass Device - October 31, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Medtronic Source Type: news
Claret Medical raises $21m to support Sentinel system
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted last week.
In a press release posted today, the company said that it raised $14.5 million in a Series C round led by Lightstone Ventures and joined by Easton Capital, HealthCor Partners, Incept and Sante Ventures.
Proceeds are slated to support market access program, next-gen R&D and expanding commercialization to support its Sentinel cerebral protection system.
The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medic...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news
Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device.
The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said.
The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year.
Secondary endpoints in t...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news
Short-Term Outcome and Hemodynamic Performance of Next-Generation Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annulus: A Multicenter Propensity-Matched Comparison Structural Heart Disease
Conclusions—
Albeit a similar safety profile with low clinical event rates, transcatheter aortic valve replacement with the ACURATE neo valve resulted in lower transvalvular gradients and consequently less prosthesis–patient mismatch compared with the SAPIEN 3 in patients with small annulus. These results emphasize the need of careful prosthesis selection in each individual patient.
Source: Circulation: Cardiovascular Interventions - September 26, 2017 Category: Cardiology Authors: Mauri, V., Kim, W. K., Abumayyaleh, M., Walther, T., Moellmann, H., Schaefer, U., Conradi, L., Hengstenberg, C., Hilker, M., Wahlers, T., Baldus, S., Rudolph, V., Madershahian, N., Rudolph, T. K. Tags: Aortic Valve Replacement/Transcatheter Aortic Valve Implantation Structural Heart Disease Source Type: research
Edwards Lifesciences has ‘ key events ’ around TAVR this week
Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway.
The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow.
Edwards officials expect the Sapien 3 Ultra to receive CE Mark by the end of the year, with plans for a U.S. introduction in late 2018. For the Ultra, they’ve added a taller skirt to the Sapien 3 design to improve TAVR outcomes, according to the company.
Edwards has incorporated the taller skirt initially with sizes 20, 23 and 26 mm. A...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Catheters Clinical Trials Edwards Lifesciences tavr Source Type: news
Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system.
The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation.
“We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve in a...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Medtronic Source Type: news
Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates.
The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said.
The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so.
“In pat...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news
Minimally Invasive Versus Transcatheter and Surgical Aortic Valve Replacement: A Propensity Matched Study.
CONCLUSIONS: During recent years, MIAVR and TFTAVR have experienced significant growth in volume with near-comparable short-term outcomes, while SAVR and TA-TAVR volumes have declined. These results underscore the importance of surgeons adopting MIAVR and TF-TAVR techniques in order to offer patients optimal outcomes.
PMID: 28820543 [PubMed - in process]
Source: Journal of Heart Valve Disease - August 20, 2017 Category: Cardiology Tags: J Heart Valve Dis Source Type: research
Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family
Conclusions
Across all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients.
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - August 7, 2017 Category: Cardiology Authors: Möllmann, H., Linke, A., Holzhey, D. M., Walther, T., Manoharan, G., Schäfer, U., Heinz-Kuck, K., Van Boven, A. J., Redwood, S. R., Kovac, J., Butter, C., Sondergaard, L., Lauten, A., Schymik, G., Worthley, S. G. Tags: Structural: Aortic Valve Focus Source Type: research
Image-based immersed boundary model of the aortic root.
Abstract
Each year, approximately 300,000 heart valve repair or replacement procedures are performed worldwide, including approximately 70,000 aortic valve replacement surgeries in the United States alone. Computational platforms for simulating cardiovascular devices such as prosthetic heart valves promise to improve device design and assist in treatment planning, including patient-specific device selection. This paper describes progress in constructing anatomically and physiologically realistic immersed boundary (IB) models of the dynamics of the aortic root and ascending aorta. This work builds on earlier IB mod...
Source: Physica Medica - August 1, 2017 Category: Physics Authors: Hasan A, Kolahdouz EM, Enquobahrie A, Caranasos TG, Vavalle JP, Griffith BE Tags: Med Eng Phys Source Type: research
Medtronic wins CE Mark for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery
The CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said.
“We are excited to introduce the next evolution of our Evolut TAVI platform to provide physicians in Europe with a comprehensive portfolio to ...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
Impact of health utility after thrombotic complications following total hip and knee arthroplasty
ConclusionObjective calculation of both the benefit and risks of anticoagulation in the post‐operative patient is significantly altered by including the effect on patient's quality of life utility value. Therapeutic anticoagulation in some common situations is probable to be of more detriment than benefit when considering health utility.
Source: ANZ Journal of Surgery - July 31, 2017 Category: Surgery Authors: Bikram Karmakar Tags: Original Article Source Type: research
Claret Medical raises $11m
Claret Medical has raised $11.2 million in a new round of equity financing, according to an SEC filing posted this week.
Money in the round came from 34 unnamed investors, according to the SEC filing, with the 1st sale dated on June 22.
Claret Medical is still looking to raise an additional $6.5 million in the round, according to the SEC filing. The company has not yet stated how it intends to use funds raised in the round.
The Santa Rosa, Calif.-based company produces the Sentinel embolic protection device designed to trap blood clots and prevent stroke during heart valve replacement procedures.
The Sentinel device uses a...
Source: Mass Device - July 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news
