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

Who’s Sorry Now? The ABIM, That’s Who

sorry_140sqThe lyrics of the 1923 song go like this: “Who’s sorry now, who’s sorry now? / Whose heart is achin’ for breakin’ each vow?”

And today, it was the American Board of Internal Medicine (ABIM) who said they were sorry for breaking the hearts of all the cardiologists in the U.S. of A.

They wrote specifically: “We got it wrong and sincerely apologize. We are sorry.Continue reading

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Filed under ACC, Media Coverage, Medical Education, SCAI

NBPAS Launches Alternative to MOC

   Today’s the day that The National Board of Physicians and Surgeons (NBPAS) officially launches. Briefly stated, it’s an alternative certification organization, set up by Dr. Paul Teirstein and a group of physicians, mostly cardiologists, who strongly objected to the Maintenance of Certification assessment track established by the American Board of Internal Medicine (ABIM).

You can read more about it in my post from last week, “Scalpel…Suture…Suction…Pencil?” and in Dr. Teirstein’s New England Journal of Medicine article, titled “Boarded to Death — Why Maintenance of Certification Is Bad for Doctors and Patients.

I’ll be following the progress of this initiative, but a few recent articles and developments bring up some interesting points. Continue reading

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Scalpel…Suture…Suction…Pencil?

  The buzz going around the medical community this week is Dr. Paul Teirstein’s article in today’s New England Journal of Medicine, titled “Boarded to Death — Why Maintenance of Certification Is Bad for Doctors and Patients,” in which he skewers the imposition of the Maintenance of Certification (MOC) requirement put into place a year ago by the American Board of Internal Medicine (ABIM).

The concept of the MOC was to ensure that physicians who had been certified in their specialty kept current with medical practice and the current guidelines. It’s not that concept that Dr. Teirstein objects to, but its heavy-handed implementation by, as he puts it, “people not directly involved in patient care who have lost contact with the realities of day-to-day clinical practice.” Ouch!

And Dr. Teirstein is not alone in his objections. An online petition he created has garnered almost 20,000 signatures. It asks the ABIM to recall the changes in MOC and institute a simple pathway consisting of  a recertification test every ten years; a corollary petition, pledging non-compliance (read “boycott”) has over 6,000 signers – a more difficult pledge since many physicians are employed by hospital systems that require the ABIM MOC. And this certification is a monopoly, but more on that later…. Continue reading

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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

Philips Buys Volcano: It’s About Money, Technology, and History

  Rumors and theories about an acquisition of Volcano Corporation (NASDAQ: VOLC) had been circulating for quite some time: months, years even. The company seemed an obvious choice: it has an advanced intravascular ultrasound (IVUS) technology that leads the market, with Boston Scientific coming in second; it has a fractional flow reserve (FFR) wire that splits the market with St. Jude Medical; and recently Volcano gained FDA approval for its Instant Wave-Free Ratio (iFR) physiologic measurement product, a faster, cheaper potential alternative to FFR. Continue reading

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Filed under ACC, Angiograms, Back to the Future, Business & Industry, Cardiac CT, Cost Effectiveness, FFR, Global Trends, History, Imaging, Intravascular Guidance, IVUS, OCT, Video

From Bench to Bedside to Bench Revisited: Supreme Court Justice Ginsburg Back in Action

  Almost two decades ago, interventional cardiology pioneer Dr. Spencer B. King III penned an article for Circulation titled, “Angioplasty From Bench to Bedside to Bench.” Dr. King’s article was a recounting of the history of the development of the angioplasty balloon catheter by his colleague at Emory University, Andreas Gruentzig.

This morning, the title of his article took on new meaning, as Supreme Court Justice Ruth Bader Ginsburg entered the courtroom and took her seat, engaging in several complex legal arguments concerning mortgage loan officers, Facebook threats, and more. Continue reading

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Filed under Celebrity Patients, History, Media Coverage, Stent