Category Archives: FDA

Medtronic Launches Stent for Diabetics in India; Abbott Launches Absorb “Scaffold”

Medtronic’s Resolute Integrity zotarolimus-eluting stent

According to reports yesterday by the Mumbai Bureau of Pharmabiz, and confirmed today by MassDevice, Medtronic has launched its Resolute Integrity Drug-Eluting Stent (DES) in India for the treatment of coronary artery disease (CAD). The Resolute Integrity is the only stent approved by the FDA for use in diabetics, based on a large cohort of diabetic patients in the Resolute clinical program.

Diabetics historically have had higher adverse events when treated with PCI (angioplasty and stents) — but the data from the Resolute trials showed virtually no difference between diabetics and non-diabetics, leading the FDA to approve the indication. Continue reading


Filed under Clinical Trials / Studies, Diabetes, Drug-Eluting Stents, FDA, Global Trends, Stent

NEJM: Obama and Romney on the Future of Health Care

Barack Obama and Mitt RomneyPublished “online first” today in the New England Journal of Medicine are two articles, authored by the Democratic and Republican presidential nominees, President Barack Obama and former Massachusetts Governor Mitt Romney, describing their health care platforms and their visions for the future of American health care. The editors of NEJM had asked the nominees for these statements which are brief and concise, summing up the two positions in less than 1,300 words each.

President Obama’s statement, titled “Securing the Future of American Health Care,” recaps the highlights of the Affordable Care Act, passed in his first term, and lays out plans for future improvements. Continue reading


Filed under Cost Effectiveness, FDA, Health Insurance, Patients

Boston Scientific’s New Drug-Eluting Stent in the News Again

Boston Scientific's Element Stent vs. Medtronic's Integrity

Which stent platform do you think compresses more easily: Boston Scientific’s Element (top) or Medtronic’s Integrity (bottom)?

I first heard concerns about stent deformation, primarily seen in the PROMUS Element stent made by Boston Scientific (NYSE: BSX), during a presentation at a small interventional meeting last summer. The issue was then reported in two journal articles, just prior to the TCT meeting in November, where it became a topic of much attention — although most interventional cardiologists felt that it was nothing like the problem of late stent thrombosis, first seen as a “rare” event in the first generation of drug-eluting stents five years ago. Continue reading

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Filed under FDA, Stent

From Angioplasty and Stents to Aortic Valve Replacement

Andreas Gruentzig34 years ago, Andreas Gruentzig performed the first coronary angioplasty. Rather than cutting open the chest, sawing through the sternum and sewing a bypass conduit (harvested from the leg or internal mammary artery) into the coronary artery, he elegantly threaded a balloon catheter to the blockage through a small incision in the femoral (groin) artery, in an awake patient. He then inflated the balloon, compressing the plaque against the arterial wall and opening the artery. The procedure was a total success and his first patient, Adolph Bachmann, is alive and well today! (see video clip: ” The 1st Angioplasty”.)

But more importantly than just inventing angioplasty, Gruentzig invented a method for treating patients non-surgically, from the inside-out! What Gruentzig said was: Continue reading

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Filed under Clinical Trials / Studies, FDA, History, Innovators