Medtronic said today that it had received approval from the FDA to market its In.Pact Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the upper leg. The device is the second DCB to gain FDA approval. Last October the FDA approved CR Bard’s Lutonix DCB for a similar indication.
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The FDA today announced that it had approved for use in the US the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the thigh and knee (superficial femoral and popliteal arteries). The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012.
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Giving an ACE inhibitor to people with peripheral artery disease (PAD) and intermittent claudication reduces pain and increases walking time, according to a new study published in JAMA. Currently the pharmacologic options for this patient population are few and have limited efficacy.
Researchers at three Australian hospitals randomized 212 patients with PAD to receive the ACE inhibitor ramipril or placebo for 24 weeks. Compared to the patients on placebo, patients on the ACE inhibitor had a mean 75 second increase in their pain-free walking time (156 seconds in the placebo group versus 229 seconds in the ramipril group, p<0.001) and a 255-second increase in their maximum walking time (259 seconds in the placebo group versus 512 seconds in the ramipril group, p<.001). The ACE inhibitor was also associated with improvements in other secondary measures of walking and physical quality of life.
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The FDA today approved Cook Medical’s Zilver PTX stent. It is the first drug-eluting stent (DES) approved for the treatment of peripheral arterial disease (PAD) in the superficial femoral and proximal (i.e., above the knee) popliteal artery. The new stent will provide a new treatment option for treating patients with PAD. Current treatments include exercise, drug therapy, balloon angioplasty, bare-metal stents, and surgical bypass.
“The clinical study demonstrated that the Zilver is more effective than balloon angioplasty for the treatment of symptomatic peripheral artery disease in above-the-knee femoropopliteal artery,” said Christy Foreman, of the FDA’s Center for Devices and Radiological Health, in an FDA press release. “This approval expands the treatment options for patients suffering from symptomatic peripheral artery disease to include the Cook Zilver PTX drug eluting stent.”
The FDA said the Zilver PTX stent is contraindicated in people with “stenoses that cannot be dilated to permit passage of the catheter or proper placement of the stent, patients who cannot receive recommended drug therapy due to bleeding disorders, or women who are pregnant, breastfeeding, or plan to become pregnant in the next five years.” In clinical studies the most common major adverse event associated with the stent was restenosis requiring treatment to restore patency.
The FDA is requiring Cook Medical to perform a five-year post-approval study of 900 patients.
“This approval marks the start of Cook’s program to bring the benefits of drug elution to U.S. physicians treating the peripheral arteries,” said a Cook Medical executive, Rob Lyles. He said that Cook Medical intends by the end of 2013 to offer a “full suite of drug-eluting peripheral stents in the most commonly used lengths and diameters.” The Zilver PTX will be initially available in an 80 mm length in 6 mm and 7 mm diameters. The company has also received approval to market 40 and 60 mm length stents, though these will not be available until early 2013. Cook said that it expects to receive FDA approval for a 120 mm length stent next year.
Click here to read the FDA and Cook Medical press releases…
High levels of a manmade chemical widely used in common household products and detectable in more than 98% of people may increase the risk of cardiovascular (CV) disease and peripheral arterial disease (PAD), according to a study published in Archives of Internal Medicine. (The study was published online in September and will appear in this week’s print edition of Archives.)
Anoop Shankar and colleagues measured serum levels of perfluorooctanoic acid (PFOA) in 1,216 people participating in the National Health and Nutritional Examination Survey (NHANES) and found a strong correlation between PAD and CV disease and PFOA levels. After adjusting for other risk factors, people in the highest quartile of PFOA levels had about double the risk of CV disease and PAD:
- Odds ratio for the top quartile of PFOA: CV disease 2.01 (1.12-3.60), PAD 2.78 (1.03-3.08), CVD or PAD 2.28 (1.40-3.71)
The authors cite several studies that support the plausibility of a harmful effect of PFOA. They duly note the risk of “residual confounding and reverse causality” but write that if their findings are replicated “the population-attributable risk of PFOA exposure on CVD risk could potentially be high.”
In an invited commentary, Debabrata Mukherjee acknowledges the limitations of the study but writes that there is enough biological plausibility in the relationship so that “it would make sense to limit or to eliminate the use of PFOA and its congeners in industry through legislation and regulation while improving water purification and treatment techniques to try and remove this potentially toxic chemical from our water supply.” But, he warns concerns about PFOA “should not dissuade us from aggressively managing known existing risk factors for CVD such as dyslipidemia, smoking, hypertension, diabetes, obesity, and lack of regular physical activity.”
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Although peripheral artery disease (PAD) raises the risk of heart disease and stroke, it often goes undiagnosed and untreated, especially in women, according to a scientific statement issued by the American Heart Association and published in Circulation.
Here are a few highlights of the statement:
- Although women develop PAD later than men, the total number of women with PAD is greater than the number of men.
- Like men, most women with PAD do not present with “classic symptoms” of intermittent claudication; rather, many are asymptomatic or have atypical leg symptoms.
- Women with PAD are more likely than women without PAD to have greater functional impairment and a more rapid functional decline. Women, and black women in particular, have a greater risk for graft failure and limb loss than men.
- Although women have slightly lower normal ABI levels than men, physicians should use the same diagnostic criteria for PAD in men and women.
- Although the evidence is limited because of the underrepresentation of women in clinical trials, exercise training is equally effective in men and women.
- At-risk women should be educated about PAD risk factors, symptoms, and cardiovascular risk by all healthcare providers.
“The rate of deaths and the healthcare costs associated with PAD are at least comparable to those of heart disease and stroke,” said the lead of the author of the AHA statement, Alan Hirsch, in an AHA press release. “Women, in particular, suffer an immense burden from peripheral artery disease, yet current data demonstrate most women still remain unaware of their risk.”
Adapted with permission from Physician’s First Watch.
Click here to read the AHA press release…