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Medtronic's IN.PACT Drug-Coated Balloon: First to Gain FDA OK for Treatment of In-Stent Restenosis in the Peripheral Vessels
IN.PACT™ Admiral™ drug-coated balloon (DCB)
The FDA has approved the 1st drug-coated balloon in the U.S. for treatment of in-stent restenosis in the peripherals: Medtronic's IN.PACT Admiral drug-coated balloon. One-year outcomes from the IN.PACT Global ISR Imaging Cohort were: primary patency rate of 88.7%; clinically-driven target revascularization rate of 7.3%.
NORSTENT: Drug-Eluting Stents – Doing What They’re Supposed To
HawkOne atherectomy device and IN.PACT drug-coated balloon
At this week’s annual European Society of Cardiology Congress in Rome, an important randomized clinical trial on stents was presented by Professor Kaare H. Bønaa, MD, PhD. Called NORSTENT, short for the “Norwegian Coronary Stent Trial,” this was the largest stent trial ever conducted, with 9,013 patients followed for six years. That’s serious!
AimRADIAL Masterclass V + FFR Workshop in Budapest
CoreValve® Evolut® R Transcatheter Aortic Valve in situ
On September 22-23, 2016, the 5th Advanced International Masterclass on the Transradial Approach will be held in Budapest, Hungary. And this year, AimRADIAL will be preceded on September 21 by a one-day comprehensive workshop covering all aspects of Fractional Flow Reserve (FFR) from the basic principles and set-up in the cath lab, to the differences between FFR, iFR, and CFR, a comprehensive review of the clinical study data so far, and finally a look at future modalities, like FFR-CT.
Can Drug-Coated Balloon plus Atherectomy Be a Successful Treatment for Calcified FemPop PAD?
HawkOne atherectomy device and IN.PACT drug-coated balloon
Medtronic and VIVA Physicians have launched the REALITY study: to see if directional atherectomy, combined with a drug-coated balloon, is a successful therapeutic option for these difficult cases of calcified and symptomatic femoropopliteal peripheral artery disease (PAD). The study will enroll around 150 patients, who will be followed up to two years.
CoreValve Evolut R First TAVR to Receive CE Mark for Intermediate Risk Patients
CoreValve® Evolut® R Transcatheter Aortic Valve in situ
Medtronic's recapturable and repositionable CoreValve Evolut R System has received the CE Mark to treat patients with severe aortic stenosis who are at intermediate risk for open-heart surgery, making this the first TAVR device to obtain approval for this patient population. Previously TAVR devices were indicated for use only in patients at high risk for surgery.
Will Abbott's Absorb Bioresorbable Vascular Scaffold Revolutionize Treatment of Coronary Artery Disease?
Absorb BVS with question mark
In Part One of this feature, we reported on the various positives and negatives of the BVS, as presented to the FDA panel that recommended approval. Now that this device has been approved by the FDA, we discuss in Part Two the Absorb's potential impact in the U.S. with three leading interventional cardiologists, Drs. Ajay Kirtane, James Blankenship, and Daniel Simon.
Patient Education About Aortic Stenosis? There's an App for That!
Aortic Stenosis Patient Journey iPad App
An easy-to-use iPad app, explaining aortic stenosis, its treatment options and what happens after discharge from the hospital, has been developed by Medtronic. Dubbed the "Aortic Stenosis Patient Journey iPad App," nursing staff, as well as patients and their family, can download this tool from the iTunes store for free.
COURAGE: Does 15-Year Data Have Any Clinical Relevance?
Pills and stent
From the Editor: "I think that this 15-year analysis has so many statistical weaknesses, and is looking at a snapshot in time that has long been surpassed by advances in technology and practice, that the conclusion of this “extended survival analysis” is basically irrelevant to current practice."
European Guidelines Say "Radial First"
transradial access
Today the European Society of Cardiology (ESC) gave the highest recommendation to the radial (wrist) approach for catheter-based interventions in patients with acute coronary syndromes (ACS). The "ACS without persistent ST-segment elevation (NSTE-ACS) guidelines," drafted by an international multidisciplinary Task Force, were introduced as part of this year's annual ESC meeting, and are now published online.
"A Type of Interventional Radiology": A Quaint Memory from the New York Times
NY Times Magazine from 1983
I recently was rifling through some old files of news clippings (you remember those pesky things, don't you?) and came across a major New York Times Magazine feature from 1983. It was titled, "Toward the Conquest of Heart Disease." Near the end of the article, the author briefly mentions something he calls "a type of interventional radiology" which has "great potential advantages but remains experimental."
Medtronic Begins Trial for Next-Generation Drug-Eluting Stent in Small Arteries
Medtronic Resolute Onyx stent picture on map of U.S.
Medtronic is beginning the U.S. pivotal trial for its new drug-eluting stent, the Resolute Onyx™. The Onyx received the European CE Mark in November and has been available in countries that recognize the CE Mark. The first phase of this trial will be studying one of the most challenging clinical scenarios: blockages in arteries that measure as small as 2.0mm.
Consumer Reports Overstates Cardiac CT Radiation Dose
Cardiac CT 3D image
Consumer Reports regularly publishes health information to aid the consumer/patient in making decisions. That's good, but also important is having the most current information, which their recent article about CT scans does not. The article states that a Cardiac CT Angiogram (CTA) exposes the patient to 12 mSv of ionizing radiation, or 120 times that of a chest X-ray. This was true years ago, when CTA was first being used to diagnose coronary artery disease. But it is not true today.
Medtronic Launches Drug-Coated Balloon for Peripheral Artery Disease in U.S.
Maintenance of Certification exam and OR
The IN.PACT Admiral is the second such device approved by the FDA, the first being Bard's Lutonix back in October. The approval was supported by a body of clinical evidence of 21 studies involving more than 3,500 patients worldwide, demonstrating the best clinical outcomes of any medical technology for the treatment of PAD in the SFA and popliteal arteries.
Who's Sorry Now? The ABIM, That's Who
Upper leg arteries (superfiical femoral and popliteal)
The American Board of Internal Medicine (ABIM) has apologized to the medical community saying they "had gotten it wrong." What the ABIM had gotten "wrong" was the Maintenance of Certification (MOC) changes passed a year ago. Many physicians had objected to what they felt were onerous, time-consuming, worthless and expensive requirements.
Philips Buys Volcano: It's About Money, Technology, and History
Volcano and Philips logos
The acquisition of Volcano by Philips is a landmark event in the world of imaging. For years, Volcano's mantra was "angiography alone is not enough." Well now, angiography agrees and one of the largest manufacturers of cath labs will be offering IVUS, FFR and iFR modalities as part of its total imaging package. The potential spread of these technologies can only benefit patients, with better outcomes and more targeted procedures, and also save hospitals and healthcare systems money.
FDA Approves HeartFlow FFR-CT: Non-Invasive Method for Determining Coronary Ischemia
HeartFlow FFR-CT 3D Analysis
The FDA has approved HeartFlow's FFR-CT software for measuring coronary blockages non-invasively. While the accuracy of FFR-CT to correctly differentiate significant blockages from those not needing revascularization is only in the mid-80% range, the fact that a CT scan can be performed quickly, non-invasively, and with relatively low radiation doses, makes this procedure a significant contender to the extremely common nuclear stress test, and a potential game-changer in the diagnosis of coronary artery disease.
DAPT Study: Extended Treatment After Stenting Lowers Stent Thrombosis and Heart Attacks
Plavix and stent
"Longer is better." That's what Dr. Dean Kereiakis told Angioplasty.Org when characterizing the results of the long-awaited Dual Antiplatelet Therapy (DAPT) study, which were presented today at the annual American Heart Association Scientific Sessions in Chicago. Dr. Kereiakes is the co-principal investigator for this five year study of 10,000 patients, which adds to the knowledge base of whether long-term treatment with aspirin and a thienopyridine, such as Plavix, after stent implantation is beneficial to patients.
FFR and iFR: Roadmapping Your Heart, With Traffic
Road map with traffic
What has become clearer in the past few years is that seeing is not believing. The angiogram may show a narrowing, but that narrowing may not be causing a reduced flow of blood to the heart, a.k.a. "ischemia." Stenting or bypassing such a "non-ischemic" narrowing may not be of much benefit to the patient, but it will add a small risk factor of stent restenosis or perhaps a surgical complication.
ZEUS: Drug-Eluting Stent Outperforms Bare Metal for Safety and Efficacy in At-Risk Patients
The ZEUS trial of 1,606 patients showed that the use of Medtronic's Endeavor zotarolimus-eluting stent is associated with a lower risk of major cardiac events at one year compared to bare metal stents among a patient population normally excluded from treatment with drug-eluting stents.
FDA Approves Volcano's iFR® Pressure Measurement Modality for Use in Coronary Stent Guidance
Volcano's iFR system measures intracoronary pressures without need for adenosine
The FDA has granted approval to Volcano's proprietary coronary pressure measurement modality, iFR (Instant wave-Free Ratio). iFR represents a significant advance in the field of functional measurement (FM), in which the actual flow pressures inside the coronary artery can be measured and the deficit caused by a coronary blockage or lesion can be accurately assessed.
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.
Interventional Cardiologist Dr.Ron Caputo
"Transradial Has Gone From a Physician-Centered to an Institutional Concern."
Interview with Dr. Ron Caputo
The landscape of transradial has changed in the past 5 years from introductory "evangelical" didactic lectures to mentorship and adoption by hospitals for economic benefit and improved patient care..

Angioplasty News

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FDA OKs New Recaptureable CoreValve TAVR for Patients with Large Anatomies (Oct 26)
Coronary Angioplasty Enters Its 40th Year (Sep 16)
Medtronic's IN.PACT DCB Gets FDA OK for ISR in Peripherals (Sep 13)
NORSTENT: Drug-Eluting Stents – Doing What They’re Supposed To (Aug 30)
Medtronic Technologies Improve Delivery of Cardiac Resynchronization Therapy (Aug 29)
New Long-Term Data Reinforce Safety Benefits of the World's Smallest Pacemaker (Aug 28)
AimRADIAL Masterclass V + FFR Workshop in Budapest (Aug 25)
Edwards SAPIEN3 Gets FDA OK for Intermediate Risk Patients (Aug 21)
Drug-Coated Balloon + Atherectomy for Calcified FemPop PAD? (Aug 4)
Urgent Recall for Lotus Valve (Aug 3)
CoreValve TAVR Gets CE Mark for Intermediate Risk patients (Aug 1)
Will Abbott's Absorb Bioresorbable Vascular Scaffold Revolutionize Treatment of CAD? (July 24)
Health Canada Approval for Abbott's Absorb "Dissolving Stent" (July 14)
FDA OK to 150mm IN.PACT DCB for Long Lesions in SFA (July 13)
Absorb Bioresorbable Vascular Scaffold Gets FDA OK (July 5)
Philips Volcano Activities at EuroPCR (May 15)
InterZENtion: Transradial PCI as an Art (May 13)
An American Cardiologist in Paris (May 11)
FDA Approves World's Smallest Pacemaker for U.S. Patients (Apr 6)
CoreValve: 3-yr Survival Advantages Over Surgery in High Risk Aortic Stenosis Patients (Apr 3)
30 Day Data on Medtronic's Drug-Filled Stent (Apr 3)
CoreValve Bests SAVR in "Intermediate Risk" Aortic Stenosis Patients (Apr 2)
Philips Volcano: 5,000+ Patients Enrolled in 3 iFR Trials (Apr 1)
Low-Risk Trial for CoreValve Evolut R Enrolls 1st Patients (Mar 31)
ACC/AHA Update Guidelines for Dual Antiplatelet Therapy (Mar 29)
FDA Panel Recommends Abbott's Absorb Bioresorbable Vascular Scaffold - Part 1 (Mar 21)
Opsens Receives FDA 510(K) Clearance for the OptoWire II (Mar 16)
St. Jude's Nanostim Gets CE Mark for MRI Compatibility (Mar 10)
CoreValve Evolut R "Real World" TAVR Study Begins (Mar 7)
Pete Nicholas to Retire from Boston Scientific Board Chair (Mar 6)
FDA Approves New CoreValve Low-Risk TAVR Study (Feb 22)
CE Mark to Medtronic's Full Line of CRT-Defibrillators for Compatibility with MRI Scans (sFeb 22)
CE Mark for Boston Scientific's Eluvia Peripheral DES (Feb 22)
Medtronic's Solitaire Stent Retriever Improves Ischemic Stroke Outcomes, Reduces Mortality for 80+ (Feb 18)
Study of Medtronic's Valiant TAAA (Thoracoabdominal Aortic Aneurysm) Stent Graft Begins (Feb 10)
"Alarming" Increase in Heart Attacks Among Young Adults in India Due to Smoking and Lifestyle (Feb 10)
Real-World Comparison: Similar Efficacy for Lutonix® & IN.PACT™ Drug-Coated Balloons (Feb 9)
St. Jude Launches Mobile OCT/FFR/Angio System for Cath Labs in Europe and Japan (Feb 9)
FDA Nod to Medtronic MR-Conditional CRT-Defibrillators (Feb 5)
FDA OKs Expanded Patient Population for CoreValve (Feb 3)
CE Mark for 4.5 and 5.0mm Sizes of Medtronic Resolute Onyx Drug-Eluting Stent (Feb 1)
FDA Panel to Look At Data on Medtronic's Miniature Leadless Micra® Pacing System (Jan 29)
Patient Ed About Aortic Stenosis? There's an App for That! (Jan 25)
Svelte Launches Slender IDS Stent-on-a-Wire System in Europe (Jan 24)
Clinical Trial of Novel Infusion Device for Below the Knee Angioplasty Begins in Germany (Jan 21)
Edwards Receives FDA Approval For Expanded Indication Study Of SAPIEN 3 Valve (Jan 15)
CE Mark for Medtronic's IN.PACT Admiral DEB: to keep AV access viable for dialysis patients (Jan 11)
Medtronic to Build New Plant in Ireland for Manufacturing the IN.PACT Drug-Coated Balloon (Dec 17)
Svelte's Stent-on-a-Wire Gains CE Mark (Dec 15)
Happy 100th Anniversary to the RSNA (Nov 30)
Four Year Data for Medtronic's Endurant AAA Stent Graft Shows Durable, Consistent Outcomes in Real-World Setting (Nov 30)
COURAGE: Does 15-Year Data Have Any Clinical Relevance? (Nov 15)
IN.PACT Drug-Coated Balloon Cost-Effective (Nov 2)
Eric Topol & Paul Teirstein to do book signing at TCT (Oct 13)
Medtronic's Drug-Filled Stent: First Data (Oct 13)
FDA Approves Boston's SYNERGY Bioabsorbable Polymer DES (Oct 5)
AimRADIAL Masterclass IV in Liverpool (Sep 7)
Frontiers in Cardiology – One Day Course in New Jersey (Sep 3)
Brilinta (Ticagrelor) Gets Expanded Indications from FDA (Sep 3)
Medtronic Acquires Medina Medical (Aug 31)
Medtronic Study Detects Gene Associated with Sudden Cardiac Death (Aug 31)
Radial Revolution in the U.S. (Aug 29)
European Guidelines Say "Radial First" (Aug 29)
"A Type of Interventional Radiology": A Quaint Memory from NYT (Aug 25)
Medtronic Moves into Mitral Valve Replacement (Aug 25)
WomenHeart to Host 1st Women's Heart Health Summit (Aug 19)
Mount Sinai Launches TWILIGHT: Is Ticagrelor Alone Superior to DAPT Post-PCI? (Aug 11)
Medtronic Launches the Entrust™ Delivery System in the U.S. (Aug 5)
FDA Approves New Repositionable and Recapturable CoreValve from Medtronic (Jun 23)
FDA OKs Edwards Sapien 3 Transcatheter Aortic Valve (June 17)
Medtronic Initiates U.S. Launch of
Fortrex™ PTA Balloon
(Jun 10)
FDA OK for St. Jude to Resume Portico TAVR Trial (Jun 3)
Medtronic Drug-Coated Balloon for Peripheral Arterial Disease: Strong Results in Long Lesions (May 20)
Drs. Kiemeneij & Saito Honored at EuroPCR for Contributions to Transradial PCI (May 20)
Tiny Micra® Transcatheter Pacemaker Meets Initial Safety & Performance Measures (May 15)
Medtronic Micra® Transcatheter Pacemaker Data Presented (May 14)
Medtronic Starts Feasibility Study of Valiant 'Mona LSA' Branch Thoracic Stent Graft System (Apr 21)
iFR & iFR Scout to be Featured in Live Online Complex PCI Case (Apr 12)
HawkOne Directional Atherectomy Device for PAD Launched (Apr 9)
3-yr EverFlex™ Stent Data Published; Shows Sustained Patency (Apr 1)
Medtronic Begins SPYRAL Renal Denervation Study (Apr 1)
FDA Approval for CoreValve "Valve-in-Valve" procedure (Mar 31)
Medtronic's CoreValve Gains Approval in Japan (Mar 30)
Robert Cascella to Lead Philips' Global Imaging Businesses (Mar 30)
ACC Reacts to CMS' Proposed Rule for Meaningful Use Stage 3 (Mar 20)
CoreValve: Survival Benefit Over Open Surgery at 2 Years (Mar 14)
Medtronic CoreValve® Evolut™ R System Yields Exceptional Outcomes in First Clinical Study (Mar 14)
SCCT Statement on the PROMISE Clinical Trial (Mar 14)
Medtronic Begins Testing a "Drug-Filled Stent" (Mar 14)
Volcano Gets CE Mark for iFR Scout Pullback Software (Mar 12)
Medtronic Begins Trial for Next-Generation Drug-Eluting Stent in Small Arteries (Mar 12)
Consumer Reports Overstates Cardiac CT Radiation Dose (Mar 11)
SCCT Names Norm Linsky New Executive Director (Feb 27)
Medicare Approves Drug-Coated Balloons for Outpatient Leg Angioplasty (Feb 26)
Philips Acquisition of Volcano Completed (Feb 17)
Medtronic Gets CE Mark for Euphora Semicompliant Balloon (Feb 16)
Clinton and Eisenhower: Presidents, Hearts, Stents and 55 Years (Feb 15)
Svelte & ASAHI to Collaborate on Fixed Wire Stent System (Feb 15)
AHA-ASA & Medtronic Collaborate to Reduce Recurrent Strokes (Feb 13)
Medtronic ICMs Detect Atrial Fibrillation in Stroke Patients in 'Real-World' Study (Feb 11)
Boston Scientific to Distribute Bard's Lutonix Drug-Coated Balloon for Blockages in Leg Arteries (Feb 10)
The NBPAS Expands Certification Program (Feb 6)
Medtronic Launches Drug-Coated Balloon for PAD in U.S. (Feb 5)
Philips Extends Tender Offer Period to Feb 17 to Acquire Volcano (Feb 5)
Medtronic Gets CE Mark for Larger Sizes of CoreValve (Feb 5)
Who's Sorry Now? The ABIM, That's Who (Feb 4)
ABIM Announces Immediate Changes to MOC Program (Feb 3)
CoreValve: Survival & Safety Benefit Compared to Open Surgery for Patients with Prior CABG (Jan 28)
FDA Approves Melody Transcatheter Pulmonary Valve (Jan 27)
Medtronic Completes Acquisition of Covidien (Jan 26)
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Plavix and Stent
Patient Alert!: How to Get the Best Price on New Generic Plavix
Our survey found prices from 35¢ to $6 per pill. Read on for more resources to help you get the most affordable antiplatelet drugs, plus a look at the role of online patient communities.
5 Crucial Questions To Ask Your Doctor About New Heart Disease Treatments
Make sure you are benefiting from the most up-to-date research, and have access to the treatments that best fit your needs and preferences.
   Doctor and Patient
Radial Hospital Locator
A list of physicians and hospitals offering the transradial (wrist) approach to angiograms, angioplasty and stent procedures.
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Read patient stories and Learn about medications after stenting, symptoms and complications, care giving, taking charge of your health, communicating with your cardiologist and much more in our Patient Center.
Angioplasty Inventor, Dr. Andreas Gruentzig
see video clip:
" The 1st Angioplasty"
ANGIOPLASTY AT 35: 2012 marked the 35th 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.
(View videos, interviews, and photos in our Angioplasty History Center, or order our DVD, "PTCA: A History.") Angioplasty History DVD
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