Non-Invasive FFR Gets Boost from Medtronic
FFRangio was developed by CathWorks, an Israeli company, and was approved by the US FDA in 2018, and a year later by the Ministry of Health, Labour and Welfare in Japan. The pivotal study that led to FDA approval, FAST-FFR, showed that angiography-derived FFR was highly accurate when compared with pressure-wire FFR. This week Medtronic announced that it was investing $75 million in the company, co-promoting its use, and has an option to acquire CathWorks for $585 million, once certain milestones are met. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - July 17, 2022 Category: Cardiology Source Type: news
Two-Year Results from Onyx ONE Trial: No Difference Between Onyx DES and BioFreedom DCS
The results, consistent with the outcomes seen at one year, showed that at two years there were no differences between HBR patients on one month of DAPT who received the Onyx permanent polymer drug-eluting stent (DES), made by Medtronic, and those who received the BioFreedom polymer-free drug-coated stent (DCS), made by Biosensors. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 9, 2022 Category: Cardiology Source Type: news
Late-Breaking Data Reinforce Broad Range of Patients Benefit from Abbott's Mitral and Tricuspid Heart Valve Devices
MitraClip, manufactured by Abbott
Abbott today announced late-breaking data for MitraClip ™, the world's first transcatheter edge-to-edge repair (TEER) device, and TriClip™, a first-of-its kind minimally invasive tricuspid heart valve repair device. The data reinforce the capabilities of the company's structural heart solutions for both mitral and tricuspid regurgitation (MR and TR) across a broad range of patient groups battling leaky heart valves (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 8, 2022 Category: Cardiology Source Type: news
Renal Denervation for Controlling Hypertension Featured at EuroPCR
At this year's EuroPCR meeting in Paris, the largest European conference in the field of interventional cardiology, the topic of renal denervation (RDN) resurfaced with significant positive results from several trials across devices. The bottom line was that in these sham-controlled trials, renal denervation provided an additional therapeutic avenue for those patients who are unable to control their hypertension with lifestyle changes and medications. In all the studies presented, RDN lowered blood pressures whether the patient was on or off medications. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 6, 2022 Category: Cardiology Source Type: news
Shockwave Medical and Genesis MedTech Obtain Regulatory Approval in China for Intravascular Lithotripsy
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, and Genesis MedTech Group announced today that they have successfully obtained approval from China ’s National Medical Products Administration (NMPA) to market and sell the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheters and the Shockwave M5 and S4 Peripheral IVL Catheters in China. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - May 23, 2022 Category: Cardiology Source Type: news
Significantly Improved Results for Medtronic's Evolut TAVR seen in the Optimize PRO Study
At this year's EuroPCR meeting, the interim results of the Optimize PRO study of Medtronic's Evolut ™ PRO and PRO+ TAVR systems in 400 patients were presented as a Hotline Trial: permanent pacemaker rates dropped to single digits (9.2%) and the number of patients with moderate or severe paravalvular leak (PVL) was zero (78% of patients had no or only trace PVL). Moreover, the median length of ho spital stay was one day. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - May 22, 2022 Category: Cardiology Source Type: news
Intravascular Lithotripsy May Emerge as a First-Line Therapy for Calcified Lesions in Women
“Given the established safety profile of IVL and the high rates of acute and long-term adverse events in women undergoing PCI, with or without atheroablation of calcified lesions, coronary IVL is an attractive treatment option for optimizing outcomes in our female patients,” said Alexandra Lansk y, MD, FACC, FAHA, FSCAI, FESC, Professor of Medicine (Cardiology); Director of Yale Cardiovascular Clinical Research Program, Yale University School of Medicine, New Haven, Conn. “While this is the first one-year analysis of its kind for coronary IVL, the sustained benefit in MACE at one year sug gests that IVL should be con...
Source: News from Angioplasty.Org - May 20, 2022 Category: Cardiology Source Type: news
ITAL-neo Registry: Boston Scientific's ACURATE neo2 Valve Significantly Reduces Paravalvular Leak (PVL) from 1st Generation Device
The first generation TAVR exhibited a not insignificant moderate or greater paravalvular leak. By adding a taller external skirt for the newer device, the PVL was reduced from 11.2% down to 3.5%. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - May 19, 2022 Category: Cardiology Source Type: news
Medtronic Receives FDA Approval for Latest Generation Drug-Eluting Coronary Stent System
Design changes include increased catheter flexibility, an innovative dual-layer balloon technology and a lower crossing profile, leading to a 16% improvement in deliverability vs. the previous generation Resolute Onyx DES. Onyx Frontier offers a broad size matrix to treat more patients and is the only 2.0 mm DES available in the United States (similar to Resolute Onyx). Further, Onyx Frontier continues to provide 4.50-5.00 mm sizes that can be expanded to 6.00 mm - specifically designed to support extra-large vessels. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - May 13, 2022 Category: Cardiology Source Type: news
Society for Vascular Medicine Elects Dr. Herb Aronow as New President
"It is an honor to serve as SVM's next President and I look forward to working alongside the Board of Trustees and other Society leaders to advance the vascular medicine discipline and the care of vascular patients," Aronow said. "In collaboration with other vascular organizations, I plan to broaden our efforts around vascular education, research and quality." (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 18, 2021 Category: Cardiology Source Type: news
Complete Two-Year Data Confirms That Medtronic's Evolut TAVR System Is Non-Inferior to Open Heart Surgery in Low Risk Patients
Confirming the preliminary data that was previously presented at the 2019 Scientific Session of the American College of Cardiology, the complete data from over 1,400 patients enrolled in the Evolut Low Risk Trial was presented (virtually) at this year's EuroPCR meeting by John K Forrest, MD, FACC, FSCAI. The result: the primary endpoint of all-cause mortality or disabling stroke at two years was 4.3% for TAVR versus 6.3% for surgery (p (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 1, 2021 Category: Cardiology Source Type: news
Medtronic Announces CE Mark of Evolut ™ PRO+ TAVI System for Treatment of Symptomatic Severe Aortic Stenosis Patients in Europe
The system includes 4 valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest annular range (for self-expanding TAVI technology) on the market. The approval follows a recent indication expansion for the Evolut platform in Europe for patients with severe aortic stenosis who are at a low risk of surgical mortality and patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - May 3, 2021 Category: Cardiology Source Type: news
CMS Proposes Additional Payment for Shockwave ’s Coronary IVL in Hospital Inpatient Cases
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the Centers for Medicare and Medicaid Services (CMS) published the Fiscal Year 2022 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule, which recommended that coronary IVL cases be eligible for incremental payment via a New Technology Add-On Payment (NTAP) from CMS when performed in the hospital inpatient setting. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 27, 2021 Category: Cardiology Source Type: news
Medtronic Receives FDA Approval for "Breakthrough" Transcatheter Pulmonary Valve Replacement for Patients with Congenital Heart Disease
Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval for its Harmony ™ Transcatheter Pulmonary Valve (TPV), the 1st minimally invasive therapy created to treat patients with a specific type of congenital heart defect of the right ventricle, one of the four chambers of the heart, which makes it difficult for blood to travel from the heart to the lungs. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 26, 2021 Category: Cardiology Source Type: news
Boston Scientific Withdraws Lotus Edge ™ from Market
Originally designed as a unique aortic valve system that could be repositioned and retrieved, the Lotus ™ Valve System is now also recalled. On Tuesday, Boston Scientific announced "global, voluntary recall of all unused inventory of the LOTUS Edge™ Aortic Valve System due to complexities associated with the product delivery system." (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 21, 2020 Category: Cardiology Source Type: news
