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The Recor Paradise Renal Denervation System
Recor's Paradise Renal Denervation System Gets FDA Approval
The Paradise RDN system had been approved for the CE Mark in Europe over a decade ago, as have several other systems from Medtronic, et al, but this is the first system that has received approval to be marketed in the U.S.
Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) catheter
New Shockwave IVL Catheter to Debut at TCT 2023
Shockwave Medical, will be introducing their latest iteration of the intravascular Lithotripsy Catheter, the C2+, just approved by the U.S. FDA. The C2+ provides 50% more pulses and "will be an added benefit of IVL for optimally treating complex calcium, including more diffuse disease, as well as nodular and thick, eccentric calcium."
Medtronic's Evolut FX
TAVI system
Medtronic's Evolut FX TAVI System Gets CE Mark
Medtronic today announced that its latest iteration of the Evolut TAVI/TAVR system, the Evolut™ FX, has received the CE Mark. Although medical devices often are approved in Europe prior to US approval, the Evolut FX did the opposite: it garnered US FDA approval two years ago. Today's announcement means that this newest and most advanced transcatheter platform for treating severe aortic stenosis will now be available in Europe and beyond.
Societies Join to Form New CV Board
"It's Time!" Say 4 Cardiology Orgs Regarding Changes to the Process of Physician Certification
They no longer wish to be subject to certification by the American Board of Internal Medicine (ABIM) & are addressing the long-standing complaints of a wide range of cardiologists who claim that the certification requirements of ABIM are not in any way related to their day-to-day practice, are needlessly time-consuming, and are expensive.
Watchman FLX Pro
FDA Approves Boston Scientific's Watchman FLX™ Pro Left Atrial Appendage Closure Device
Designed to further advance the procedural performance and safety of the WATCHMAN technology, indicated to reduce stroke risk in patients with non-valvular atrial fibrillation (NVAF) who need an alternative to oral anticoagulation therapy, the device now features a polymer coating, visualization markers and a broader size matrix to treat a wider range of patients.
Dr. B. Clay Sizemore
Interview with Dr. B. Clay Sizemore About Calcium Modification with IVL in Hospitals That Do Not Have Surgical Backup
In this interview, Dr. Sizemore discusses how intravascular lithotripsy (IVL) has been a game-changer for patients with significant calcified lesions -- that instead of having to transport them to a distant hospital, he is able to safely and efficaciously treat them in Thomasville, Georgia.
Drs Margaret McEntegart and Richard Shlofmitz
Shockwave: Dual Announcements at EuroPCR -- Improved Catheter & 1st Patient Enrolled in All-Female EMPOWER Study
The Company introduced to the international market their latest iteration of the calcium-cracking coronary catheter: the C2+ which affords greater numbers of pulses to treat longer and more challenging lesions. Additionally Shockwave announced that the first patient had been enrolled in the EMPOWER study of the treatment of calcified lesions in women.
Micra Leadless Pacing System
Medtronic Receives FDA Approval For Its Next Generation Micra Leadless Pacing Systems
With approximately 40% more battery life compared to previous generations, the median projected battery life of Micra AV2 and Micra VR2 is nearly 16 and 17 years, respectively. This means more than 80% of patients who receive a Micra are projected to only need one device for life.
Medtronic's CoreValve/Evolut™ Transcatheter Aortic Valve
Three-Year Results of Medtronic's Evolut TAVR Compared to Surgery in Low Risk Patients Presented at ACC
The 3-year comparative data for Medtronic's CoreValve/Evolut TAVR vs. SAVR for low risk patients that were presented at today's late-breaking clinical trials session were much needed and the results showed that this device compared favorably with surgery and, in some respects, was superior.
Abbott's Amplatzer Amulet Left Atrial Appendage Occluder and Navitor Transcatheter Aortic Valve
New Data Show Superiority of Abbott's TriClip™ Device Compared to Medical Therapy for Tricuspid Regurgitation
Late-breaking data demonstrated TriClip was superior to medical therapy with significant improvements in quality of life and tricuspid regurgitation (TR). Findings show TriClip, an investigational device in the U.S. to treat a leaky tricuspid valve, demonstrated safety and met the primary endpoint.
Medtronic's CoreValve/Evolut™ Transcatheter Aortic Valve
Medtronic CoreValve/Evolut™ Durability Bests SAVR at 5-Years
Data were presented in a late-breaking clinical trial session at CRT 2023 by Dr. Steven Yakubov: "These results add yet another proof point demonstrating the durability benefits of TAVR compared to surgery when it comes to bioprosthetic valve dysfunction – a complication that can impact the durability and performance of a critical valve replacement."
Updated SCAI Guidance Includes Coronary IVL as a Treatment Option in All U.S. Catheterization Labs Regardless of Surgical Backup Status
Shockwave Medical, Inc. announced that coronary IVL was included in a treatment guidance document published by the Society of Cardiovascular Angiography and Intervention (SCAI) as a potential therapeutic option in all U.S. catheterization labs. - including facilities without on-site surgical backup.
SPYRAL HTN-ON MED Study Demonstrates Meaningful Clinical Benefits Consistent with Other SPYRAL HTN Renal Denervation Trials
At the American Heart Association (AHA) Scientific Sessions 2022, Medtronic announced the six-month results from the full cohort of the SPYRAL HTN-ON MED clinical trial. With this news, the final module of the Symplicity Spyral™ Premarket Approval (PMA) package has been submitted to the U.S. Food and Drug Administration (FDA) for review and approval.
Dr. Alexandra Lansky
Shockwave Medical Initiates All-Female Coronary IVL Study
EMPOWER CAD is the 1st prospective, female-only study of coronary interventions. The study seeks to confirm benefits of Shockwave’s coronary IVL in females who historically have suffered less favorable clinical outcomes than male patients with traditional therapies. The study is headed by two female co-principal investigators, Drs. Alexandra Lansky and Margaret McEntegart, and will have a prevalence of female site investigators in the U.S. and Europe.
Interventional Cardiologist Dr. Sanjay Patel
"The Whole Story is About Increasing Patient Happiness."
Interview with Dr. Ferdinand Kiemeneij
In this two-part 20th anniversary interview, the "father of transradial intervention, " talks about the history and future of TRI.

Angioplasty News

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Recor's Paradise Renal Denervation System Gets FDA Approval (Nov 13)
New Shockwave IVL Catheter to Debut at #TCT2023 (Oct 21)
Medtronic's Evolut FX TAVI System Gets CE Mark (Oct 12)
"It's Time!" Say the Major Cardiology Organizations Regarding a Change to the Process of Physician Certification (Sep 21)
FDA OKs Boston Scientific's Latest Iteration of the Watchman Left Atrial Appendage Closure Device: the FLX Pro (Sep 6)
Interview with Dr. B. Clay Sizemore about calcium modification with IVL in rural hospitals that do not offer surgical backup (Aug 11)
Centers For Medicare & Medicaid Services Creates New Hospital Inpatient Payment for Coronary Intravascular Lithotripsy(Aug 2)
Shockwave Medical: Dual Announcements at EuroPCR: New Improved Catheter and 1st Patient Enrolled in All-Female EMPOWER Study (May 18)
SCCT Honors Dr. Martha Gulati with 2023 Arthur S. Agatston Award (May 3)
Medtronic Receives FDA Approval For Its Next Generation Micra Leadless Pacing Systems (May 1)
Shockwave Medical Announces U.S. Launch of New Peripheral IVL Catheter (Mar 14)
3-Year Results of Medtronic's Evolut TAVR Compared to Surgery in Low Risk Patients Presented at ACC (Mar 5)
New Data Show Superiority of Abbott's TriClip™ Device Compared to Medical Therapy for Tricuspid Regurgitation (Mar 4)
CathWorks Announces Key Events for ACC 2023 (Mar 2)
Late-Breaking Data Reinforce Benefits of Abbott's Minimally Invasive Heart Devices (Feb 28)
Medtronic CoreValve/Evolut™ Demonstrates Best Durability (Feb 27)
Medtronic Continues to Make Significant Advances as an Inclusion, Diversity & Equity Leader (Feb 1)
Lithotripsy OK for PCI w/o Surgical Backup (Jan 31)
Medtronic Announces first Enrollment in Head-to-Head Global Randomized Trial Evaluating Durability of Endovascular Aneurysm Repair (Jan 11)
Medtronic Completes Enrollment in Pivotal Trial Evaluating First-Of-Its-Kind Pulsed Field Ablation Catheter for Patients with Atrial Fibrillation (Dec 5)
Medtronic’s Next-Gen Evolut™ FX TAVR System Shows Significant Improvement in Commissure Alignment in Real World Setting (Nov 29)
Late-Breaking Post-Market Study Data Reinforce Clinical Procedural Success and Safety of the ACURATE neo2™ Aortic Valve System (Nov 27)
SPYRAL HTN-ON MED Study Demonstrates Meaningful Clinical Benefits Consistent with Other SPYRAL HTN Renal Denervation Trials (Nov 7)
Clinical Studies Show Medtronic Drug Coated Balloon Outperforms Bare Metal Stents; Maintains Performance in Real World (Nov 2)
Medtronic is the First and Only Company to Receive FDA Indication for Bifurcation Percutaneous Coronary Intervention with a Drug-Eluting Stent (Sep 21)
FDA OKs LINQ II™ Insertable Cardiac Monitor for Use in Pediatric Patients Ages 2 and Older (Sep 20)
Shockwave Medical Initiates All-Female Coronary IVL Study (Sep 19)
3 YR Data from Pioneering RDN Study Show Sustained Reduction in Blood Pressure (Sep 18)
Medtronic Announces Full Market Launch in U.S. of Evolut™ Fx Next-Gen TAVR System for Treatment of Symptomatic Severe Aortic Stenosis (Sep 16)
Medtronic Launches Newest Drug-Eluting Stent: The Onyx Frontier™ (Aug 24)
JACC: Steep Rise in CV Risk Factors & Disease by 2060 (Aug 1)
Non-Invasive FFR Gets Boost from Medtronic (Jul 17)
2-Year Outcomes from Onyx ONE Published in JACC: Interventions (Jun 9)
1-Year Results for MitraClip EXPAND and 30-Day Data on TriCLip Presented at TVT2022 (Jun 8)
Renal Denervation for Controlling Hypertension Featured at EuroPCR (May 29)
Medtronic Low-Profile Drug-Coated Balloon Platform Receives U.S. FDA Approval to Treat Peripheral Arterial Disease (May 27)
Shockwave's Coronary and Peripheral Intravascular Lithotripsy Systems Gain Approval in China (May 23)
Significantly Improved Results for Medtronic's Evolut TAVR seen in the Optimize PRO Study (May 21)
Intravascular Lithotripsy May Emerge as a First-Line Therapy for Calcified Lesions in Women (May 19)
2nd Gen ACURATE neo2 TAVR Reduces PVL by 2/3 (May 18)
Medtronic Receives FDA Approval for Latest Generation Drug-Eluting Coronary Stent System (May 13)
Medtronic Announces First Enrollment in Pivotal Trial of Patients with Moderate, Symptomatic Aortic Stenosis (May 2)
IN.PACT™ AV Drug-Coated Balloon First and Only to Show Sustained and Superior Performance Compared to PTA Through 36 Months (Apr 27)
Medtronic Names New Chief Scientific, Medical, & Regulatory Officer (Apr 25)
BioFreedom DCS Gains Approval in Japan and U.S. (Apr 21)
Medtronic TAVR Platform First and Only To Demonstrate Durability Benefit Over SAVR At 5 Years (Apr 4)
Japan OK for Shockwave Coronary Intravascular Lithotripsy (Apr 2)
FDA Approval and First Implant of Orsiro Mission Drug-Eluting Stent System in the U.S. (Sep 30)
Medtronic Portfolio of Radial Catheters Gains CE Mark (Sep 28)
Emergency: Climate Crisis! Editorial from The Lancet (Sep 5)
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" The 1st Angioplasty"
ANGIOPLASTY AT 40: 2017 marked the 40th anniversary of coronary angioplasty. In 1977 in Zurich, Switzerland, a young physician named Andreas Gruentzig inserted a catheter into a patient's coronary artery and inflated a tiny balloon, successfully opening a blockage and restoring blood flow to a human heart.
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