Category Archives: FDA

February 26, 2015 · 9:28 pm

Medicare Approves Drug-Coated Balloons for Outpatient Leg Angioplasty

Lutonix and IN.PACT drug-coated balloons

Last week saw the U.S. Centers for Medicare and Medicaid Services (CMS) approve reimbursement for the two drug-coated balloons that recently were approved by the FDA: C. R. Bard’s Lutonix and Medtronic’s IN.PACT.

C. R. Bard’s Lutonix drug-coated balloon (DCB) was approved in October 2014, while Medtronic’s IN.PACT Admiral was approved in January of this year. Both devices have shown superior results when compared to uncoated balloons (a.k.a. “plain old balloon angioplasty” or POBA). Continue reading →

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Filed under Back to the Future, Endovascular, FDA, Health Insurance, History, Innovators, Peripheral Artery Disease (PAD), Video

January 6, 2015 · 10:35 pm

New Treatment for Peripheral Artery Disease is Approved by the FDA

Dr. Charles Dotter in LIFE Magazine (1964)

Dr. Charles Dotter in LIFE Magazine (1964)

Who is that mad scientist in the 1964 issue of LIFE magazine? Oh, just the man who invented the concept of angioplasty; in fact he’s the man who actually coined the word “angioplasty!” And he’s the doctor who performed the first angioplasties in the leg, in order to save limbs from amputation without resorting to surgery.

Like many innovators, he had a crazy idea: to open blocked arteries from the inside out. No cutting, suturing, or stitching. Less trauma, lower morbidity, quicker recovery. His name was Charles Dotter and he was a radiologist in Portland, Oregon who, 51 years ago next week, performed an angioplasty on the blocked leg artery of an 82-year-old woman. Continue reading →

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Filed under Back to the Future, Endovascular, Europe, FDA, History, Innovators, Peripheral Artery Disease (PAD), Video

October 1, 2013 · 4:56 pm

No New FDA Approvals Today!

FDA Website today (click for larger image)

FDA website today (click for larger image)

Obviously, with the Federal government in shut down mode, a situation precipitated by the House of Representatives’ demand to delay the implementation of the already-implemented Affordable Care Act (a.k.a. Obamacare), no new device approvals will be forthcoming today, or any other day, until the U.S. Government gets an infusion of start-up capital (puns intended).

Maybe a Kickstarter campaign would be in order here. Continue reading →

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Filed under FDA, Health Insurance

March 20, 2013 · 7:13 pm

FDA Panel Decision on Mitraclip Approval: It’s Safe and “Sort of” Effective

MitraClip, manufactured by Abbott Vascular

MitraClip, manufactured by Abbott Vascular

Today’s Circulatory System Devices Panel of the Medical Devices Advisory Committee heard testimony from Abbott Vascular, surgeons, cardiologists and patients.

The indications for the MitraClip Clip Delivery System that were being discussed were “the percutaneous reduction of significant symptomatic mitral regurgitation (MR=3+) in patients who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the mitral regurgitation.”

In the end, the panel voted on three questions which relate to the approvability of the device, and the envelope goes to…well here are the votes: Continue reading →

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Filed under Clinical Trials / Studies, FDA, Meetings & Conferences, Patient Empowerment, Patients

February 18, 2013 · 4:44 pm

No More Financial Assistance for Plavix from Bristol-Myers But Are Generics Really the Same?

plavix_and_stentBristol-Myers Squibb (NYSE: BMY) is no longer offering its $37-a-month Plavix® Co-Pay Discount Card. And some patients are not happy about this. Additionally, according to the company’s web site for “Patient Assistance Programs,” the company is no longer making this life-saving drug available to patients who cannot afford it. This, of course, has something to do with the fact that brand-name Plavix has gone off patent and generic versions have been available since May 2012. (See our Patient Alert: How to Get the Best Price on New Generic Plavix.) But are the generic versions of clopidogrel really the same? Continue reading →

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Filed under Antiplatelet Medications, Drug-Eluting Stents, FDA, Patient Alert, Patients

November 27, 2012 · 6:03 pm

Stents, Trials and Studies: What’s in a Word?

What's In a Word?Today the editors of the HEART Group Journals, comprising the Journal of the American College of Cardiology and other participating cardiovascular publications, issued a “Statement on Matching Language to the Type of Evidence Used in Describing Outcomes Data.”

Although the title of the article may be a bit yawn-inducing, the editors deserve a kudo or two for attempting to clarify reporting on medical issues. Continue reading →

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Filed under ACC, Appropriate Use Criteria (AUC), Clinical Trials / Studies, Drug-Eluting Stents, FDA, Media Coverage, Patients

October 15, 2012 · 7:59 pm

TCT 2012 – Transcatheter Cardiovascular Therapeutics in Miami Beach

Miami Beach

The TCT will be held in Miami Beach, October 22-26, 2012

The Transcatheter Cardiovascular Therapeutics conference (TCT) is the largest U.S. meeting devoted to interventional cardiology (angioplasty, stents, and related procedures) and it starts next week. Organizers are predicting a new attendance record of over 12,000 cardiologists and associated healthcare professionals, as well as members of the device, imaging and pharmaceutical industries, venture capitalists, and press. Speaking of which, yes…I will be there and Angioplasty.Org will be reporting on late-breaking trials, new directions and innovative devices.

The annual  meeting is truly international: attendees will be traveling from 70 countries; in fact, this year more than two-thirds of the registrants hail from outside the United States. Continue reading →

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Filed under Clinical Trials / Studies, Cost Effectiveness, FDA, Global Trends, Heart Attack, High Blood Pressure, Intravascular Guidance, Meetings & Conferences, Stent, Transradial Approach