💰 Edwards’ Evoque valve won an early nod from the FDA ✅. Edwards Lifesciences gained early FDA approval for its Evoque transcatheter tricuspid valve replacement system, marking a significant advancement in treating tricuspid regurgitation. The system, comprising a circular device encased in a metal mesh, aims to address tricuspid valve issues non-invasively. This development underscores Edwards' commitment to innovation and improving patient outcomes in cardiovascular care. The heart valve specialist has the chance to shape a new tricuspid market with the first-of-its-kind device, like it did 20 years ago in TAVR, CEO Bernard Zovighian said. #cardiology #structuralheart #tricuspid
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Recently, weight-loss medications (also called anti-obesity medications) have been taking the world by storm with increasing popularity to help people shed weight. At the beginning of March, the United States Food and Drug Administration (FDA) approved a new use for one of these medications. Wegovy (semaglutide) injection, an injectable weight-loss medication, was approved to reduce the risk of cardiovascular events, including heart attack, stroke, and cardiac-related death, in adults with cardiovascular disease who are either obese or overweight, according to the FDA. At The Valley Hospital’s Center for Bariatric Surgery and Weight-Loss Management, our team works with each patient to develop a personalized treatment plan – incorporating one or more weight-loss solutions, to help you meet your individual goals. To learn more about the Center, please visit https://lnkd.in/eATe-s2g. #WeightLoss #WeightLossMedications #MedicalWeightLoss #ValleyHealthSystem
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The FDA has approved Abbott's Esprit BTK Everolimus Eluting Resorbable Scaffold System, a breakthrough dissolving stent for treating chronic limb-threatening ischemia (CLTI) below the knee. This is the first and only dissolvable stent approved by the FDA for use below the knee, addressing a significant unmet need for CLTI patients. Prior to this, the standard of care was balloon angioplasty, which has poor short- and long-term outcomes. The Esprit BTK System is made of a material similar to dissolvable sutures and is designed to keep arteries open and deliver the drug Everolimus to support vessel healing before completely dissolving over about 3 years. Clinical trial results showed the Esprit BTK System reduces disease progression and improves outcomes compared to balloon angioplasty, marking a significant milestone in the treatment of peripheral artery disease below the knee. Abbott vascular business senior vice president Julie Tyler said: “At Abbott, we’ve recognised the significant burden of disease and limited treatment options available for people living with the most severe form of PAD. “That’s why we’re revolutionising treatments with resorbable scaffold technology below the knee. Our resorbable program is focused on meeting unmet needs in the peripheral anatomy to help people live better and fuller lives.” This innovation from Abbott is expected to transform the landscape of CLTI therapy and help improve the lives of the over 20 million Americans living with peripheral artery disease. https://lnkd.in/gz9f2S-p Be sure to follow Practical Patient Care on LinkedIn for more industry news and insights. You can also read out latest edition: https://lnkd.in/e39XTWsB #PracticalPatientCare #medicaldevices #peripheralarterydisease #FDAapproval #cardiovascularhealth
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Prognostic Implication of Vasoactive Inotropic Score in Adult Cardiogenic Shock Patients on VA-ECMO #CardiogenicShock #VAECMO #VasoactiveInotropicScore #VIS #ClinicalOutcomes #Cardiology #CriticalCare #HealthcareResearch
Prognostic Implication of Vasoactive Inotropic Score in Adult Patients with Cardiogenic Shock on VA-ECMO - Perfusion Times
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Facet Replacement: The New Motion Treatment Paradigm for Spinal Stenosis and Spondylolisthesis Patients Superior to Fusion The TOPS System is a motion preserving alternative to lumbar fusion. Instead of rigidly fixing two adjacent vertebrae, TOPS recreates normal motion after surgical decompression to eliminate nerve root impingement. Per the Food & Drug Administration, June 15, 2023: “The TOPS group demonstrated a clinically meaningful and substantial advantage over the Fusion control group, with 77% of subjects randomized to the TOPs group achieving composite clinical success, compared to 24% of subjects randomized to the fusion control. Based on these results, the TOPS System was deemed to be superior to the Fusion control with respect to composite clinical success while maintaining equivalent safety.” NTAP Approved The TOPS™ System was awarded the prestigious New Technology Add-on Payment (NTAP) by the CMS. This is only the 3rd time that CMS has granted an NTAP to a spinal implant. FromOctober 1, 2023, to September 30, 2016, qualifying TOPS procedures are eligible for up to $11,375 in additional reimbursement beyond the DRG. Further, CMS recognized the uniqueness of TOPS and awarded new ICD-10-PCS code for facet arthroplasty. Contact us: www.premiaspine.us Premia Spine
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One more way to close situations. Safely and effectively!! #CordisGoBeyond #vascularclosuredevice #venous #electrophysiology https://lnkd.in/eQCtYAfh
The MYNX CONTROL™ VENOUS Vascular Closure Device is now FDA approved! We're bringing the proven technology of the MYNX family of products to mid-bore venous puncture sites, including electrophysiology procedures. The MYNX CONTROL™ VENOUS VCD expands the Cordis portfolio of extravascular closure devices designed to deliver predictable deployment and ease of use. Leveraging GRIP TECHNOLOGY™, based on hydrophilic, bioinert polyethylene glycol (PEG), the MYNX CONTROL™ VENOUS VCD sealant resorbs 3x faster than collagen-based sealants and provides the quickest time to hemostasis of any venous closure device on the market. #CordisGoBeyond #vascularclosuredevice #venous #electrophysiology https://lnkd.in/eQCtYAfh
Cordis receives FDA approval for MYNX CONTROL™ VENOUS Vascular…
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Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System), a breakthrough innovation for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK). The Esprit BTK System keeps arteries open, delivers Everolimus to support vessel healing, and then completely dissolves. Read More: https://lnkd.in/dDcTwMA6 Until today, there were no stents or drug-coated balloons approved for use below the knee in the U.S. The standard of care has been balloon angioplasty, which relies on a small balloon delivered via a catheter to the blockage to compress it against the arterial wall, opening the vessel and restoring blood flow. However, blockages treated only with balloon angioplasty have poor short- and long-term results, and in many instances the vessels become blocked again, requiring additional treatment. “At Abbott, we’ve recognized the significant burden of disease and limited treatment options available for people living with the most severe form of PAD. That’s why we’re revolutionizing treatments with resorbable scaffold technology below the knee,” said Julie Tyler, senior vice president of Abbott’s vascular business. Columbia University Irving Medical Center #mededgemea #Abbott #MedicalDevices #FDAapproved #cardiology #MedicalInnovation #hearthealth #InnovativeTechnology #MedicalAdvancements #interventionalcardiology #HealthcareNews #medicalresearch #patientcare
Abbott's Breakthrough Dissolving Stent Receives FDA Approval
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What to know about chemotherapy ports 👇 Chemotherapy often requires frequent treatments. If that's the case for you, a chemo port can help provide a smoother and less painful process. By implanting a small device under the skin, you can protect your veins, avoid repeated needle insertions, and reduce the discomfort from traditional IV methods. Read more about what to expect here: https://bit.ly/3VcRG2F #chemotherapyport #cancersupport #digitalhealthstartup
The role of chemotherapy ports
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TAVR treatment remains low in bicuspid aortic valve stenosis patients: GlobalData - https://bit.ly/3z9zkaf | #bicuspid_aortic_valve #medical_devices #surgical_aortic_valve_replacement #transcatheter_aortic_valve_replacement
TAVR treatment remains low in bicuspid aortic valve stenosis patients: GlobalData - Express Healthcare
https://www.expresshealthcare.in
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Gore & Associates announced FDA approval of an expanded indication for the Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis. The endovascular aneurysm repair (EVAR) device is now indicated for patients with aortic neck angulation ≤ 90° and a minimum length of 10 mm. Recent data reported at 1 Year in a high neck angulation sub-study composed of 95 patients demonstrated patients experienced a low incidence of type I endoleaks and zero type III endoleaks. There were also zero reported aneurysm-related mortality, migrations, ruptures, or stent fractures.
Gore’s Excluder Conformable AAA Endoprosthesis Approved for Expanded Indication - Endovascular Today
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