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Shockwave Medical’s Intravascular Lithotripsy System
CMS Grants Transitional Pass-Through (TPT) Payment for Shockwave’s Coronary IVL
The TPT status provides incremental payment for Shockwave C2 devices used in the hospital outpatient settings. In addition, as part of the payment calculation, CMS announced that a customary deduction known as a device offset will not be applied to coronary stenting procedures involving coronary IVL. The Shockwave C2 Coronary IVL device will be eligible for TPT payments for 3 years.
Medtronic's Evolut Transcatheter Aortic Valves
2-Year Data for Evolut Confirms TAVR Non-Inferior to SAVR 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<0.0001 for non-inferiority).
Evolut™ PRO+ TAVI System
TAVI Evolut Pro+ System Receives CE Mark 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.
Philips SmartCT
FDA OK to Philips Azurion SmartCT Imaging Software
SmartCT is a key component of Philips Azurion Image Guided Therapy System, providing interventionalists with CT-like 3D images (Cone Beam CT) to support diagnosis, therapy planning, treatment and follow-up for interventional procedures.
Harmony™ Transcatheter Pulmonary Valve (TPV)
Transcatheter Harmony Pulmonary Valve Gets OK from FDA
The Harmony is 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.
Shockwave's Intravascular Lithotripsy System
FDA Grants Approval to Shockwave Intravascular Lithotripsy for Use in the Coronary Arteries
This innovative technology, which was granted Breakthrough Device designation by the FDA, is now available in the United States to treat problematic calcium in the coronary arteries, which can reduce blood flow in the heart.
Puritan Bennett™ 980 ventilator by Medtronic
*COVID-19* Cardiac Arrest Deaths at Home in NYC Have Increased By a Startling 800%
There's been a 50% or more drop in the number of people receiving emergency treatment for heart attacks in many hospitals. Physicians have been speculating why this might be. Now frightening numbers from New York City's overwhelmed emergency medical system may provide part of the answer: hundreds of people a day have been dying of cardiac arrest in their homes, an eight-fold increase over the same period last year.
Twitter poll showing significant drop in patients presenting with heart attack symptoms (MI/ACS)
*COVID-19* Doctors Say: Don't Sit Out a Heart Attack at Home
Since the onset of the novel coronavirus COVID-19, hospital emergency departments have seen a precipitous drop in the number of heart attack patients presenting for treatment. Not getting treated means heart muscle dies. What should patients do?
Medtronic Resolute Onyx Zotarolimus-Eluting Stent
FDA Approves Resolute DES for Use in Chronic Total Occlusions
The FDA today approved an expanded indication for Medtronic's family of Resolute zotarolimus-eluting coronary stents: use in the treatment of de novo chronic total occlusions (CTO). This approval includes all Resolute DES devices, including the Resolute Onyx™ and Resolute Integrity™ DES.
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5-Year Data for IN.PACT Drug-Coated Balloon in SFA Show Improved Outcomes Over Standard PTA
The IN.PACT Admiral DCB bested standard percutaneous transluminal angioplasty (PTA) for repeat interventions with almost 75% of the IN.PACT cohort of patients free from re-intervention through five-years. As for safety, there were no device or procedure-related deaths in either the DCB or PTA groups at five-years.
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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Herb Aronow New President of Society for Vascular Medicine (June 18)
CMS Grants Shockwave IVL TPT Outpatient Reimbursement (Jun 11)
2-Year Data Confirms Evolut TAVR Non-inferior to Open Surgery in Low Risk Patients (May 31)
Medtronic's Evolut Pro+ TAVI System Gets CE Mark (May 3)
Shockwave IVL May Get CMS Reimbursement (Apr 27)
FDA OK to Philips Azurion SmartCT Imaging Software (Apr 6)
Harmony Transcatheter Pulmonary Valve Gets FDA OK (Mar 26)
FDA OKs Shockwave's Intravascular Lithotripsy for the Coronaries (Feb 16)
Boston Scientific Withdraws Lotus Edge™ from Market (Nov 20)
The Resolute Onyx DES from Medtronic Receives FDA OK for 1-Month of DAPT in High-Bleeding Risk Patients (Oct 1)
Medtronic Abre Self-Expanding Venous Stent Demonstrates Favorable Outcomes in Patients (Jun 16)
Shockwave Medical: CMS Has Created New Codes for Intravascular Lithotripsy (Jun 8)
Dr. Jeffrey Popma Joining Medtronic as VP and CMO of Coronary, RDN, and Structural Heart (May 18)
Cardiac Arrest Deaths at Home in NYC Have Increased By a Startling 800% (Apr 8)
Doctors Say: Don't Sit Out Your Heart Attack at Home (Apr 6)
Pivotal Study for Shockwave's Intravascular Lithotripsy Completes Enrollment (Apr 6)
Philips Increases Ventilator Production (Mar 22)
Medtronic Ramps UpProduction of Ventilators (Mar 19)
Medtronic Begins New SPYRAL Pilot Study for RDN (Feb 4)
Interview with Tejas Patel and Samir Pancholy on Telerobotic PCI (Sep 23)
FDA OK to Medtronic's Next-Gen Evolut™ PRO+ (Sep 23)
IN.PACT AV Access Trial Meets Primary Safety and Effectiveness Endpoints (Sep 7)
FDA Fast Tracks Shockwave IVL Device Review (Sep 3)
FDA Approves SAPIEN3 TAVR for Low Risk Patients (Aug 16)
FDA Approves CoreValve Evolut TAVR for Low Risk Patients (Aug 16)
Siemens to Acquire Corindus Vascular Robotics (Aug 8)
Dr. Watanabe Discusses the Results of the STOPDAPT-2 RCT (Jul 25)
Philips Launches IntraSight Platform, integrating physiology, imaging and co-registration tools (May 20)
Bringing Japanese Know-How to the Global Market: A Visit to Shimadzu Medical Systems (Apr 24)
FDA OK to Resolute DES for Use in Chronic Total Occlusions (Feb 26)
Medtronic Valiant™ Captivia™ Demonstrates Durability, Safety, and Efficacy at Five Years in Transection Patients (Jan 30)
Philips Launches Azurion with FlexArm (Jan 17)
Medtronic Launches Mobile App for Smartphone-Connected Pacemakers (Jan 15)
Abiomed Invests $15M in Shockwave (Dec 11)
In Honor of #VEITH2018: The First EVAR (Nov 13)
Low Profile Valiant Navion Thoracic Stent System Garners CE Mark in Addition to FDA Approval (Nov 13)
VIVA: 5-Yr Data for IN.PACT DCB Show Superiority over PTA (Nov 12)
FDA Approval for Valiant Navion™ Thoracic Stent Graft System (Oct 23)
New Data for IN.PACT DCB Show Superiority/Durability over PTA (Oct 2)
Medtronic: 5-yr Outcomes for CoreValve; 2-yr Outcomes for SURTAVI (Sep 24)
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Burt Cohen, Editor of Angioplasty.Org
"Voice in the Ear": Editor Burt Cohen's stent and device blog.

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Angioplasty Inventor, Dr. Andreas Gruentzig
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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.
Today over two million coronary angioplasties are performed worldwide each year and angioplasty has become the gold standard for emergency heart attack treament.
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