A recent study performed in Germany, named the PACIFIER trial compared a drug-coated balloon to a standard balloon for treatment of lesions in femoral-popliteal anatomy.
While the results were good, and the study was well designed, it bore the hallmark of most PVD studies:
While the results were good, and the study was well designed, it bore the hallmark of most PVD studies:
- Small cohort. Most PVD studies are underpowered and shouldn't be making statistical significance claims. The reasons for this are important to note.
- Most studies are financed by industry
- Device and pharma companies make research planning decisions based on ROI
- PVD is a relatively small market when compared to coronary disease
- PVD was/is under-served with low reimbursement rates
- Interventional Radiologists traditionally have lagged surgeons in patient referrals and now Interventional Cardiologists as well in some countries.
- PVD varies greatly in its presentation and etiology depending on the location in the vascular tree. This limits the ability extrapolate data beyond the subject anatomy.
- I postulate that the combination of limited competitiveness, smaller interventional budgets, the willingness of smaller companies to lowball prices for market share, and the lack of peer reviewed proof of outcome improvements have kept the PVD therapeutic market the minor market segment it still is.
IMHO the government (NIH, CDC) must step up and address this issue. All the years of treating the problem and it is still being addressed with trickle-down products from the coronary disease market. The result is poorly targeted tools and a dearth of solid data on the complex underlying disease state.
Anybody with these co-morbidities and any kind of symptoms; calf pain, trouble walking as far as you used too, skin lesions, etc. should seek medical consultation as early as possible. I urge you, your friends and family to help raise awareness of this growing problem by any means possible.
http://www.tctmd.com/show.aspx?id=107192
This is a vein and vascular center that has multiple locations. They are located in near PHOENIX, ARIZONA, USA. Office locations are, Surprise, Arizona, USA, - Goodyear, Arizona USA, Chandler, Arizona USA and Gilbert , Arizona USA. These cities surround Phoenix, so we want to focus on each city and about a 20 mile radius around each one as well as Phoenix itself since it is in the center of all these cities.
ReplyDeleteThis is a vein and vascular center that has multiple locations. They are located in near PHOENIX, ARIZONA, USA. Office locations are, Surprise, Arizona, USA, - Goodyear, Arizona USA, Chandler, Arizona USA and Gilbert , Arizona USA. These cities surround Phoenix, so we want to focus on each city and about a 20 mile radius around each one as well as Phoenix itself since it is in the center of all these cities.
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