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Invatec has received the FDA’s 510(k) clearance to market its Reef HP, a percutaneous transluminal angioplasty (PTA) balloon catheter, for use in peripheral high pressure dilatation procedures.
Cook Medical has received FDA approval to market its balloon dilatation catheter, the Advance 35LP, which is intended for use in patients with lesions in the femoral, iliac and renal arteries.
Invatec, a provider of interventional products, has entered into a distribution agreement with interventional vascular disease treatment system developer Cardiovascular Systems, which recently merged with the biotech firm Replidyne.
C. R. Bard has received pre-market approval from the FDA to market its LifeStent FlexStar and FlexStar XL vascular stent systems for the treatment of occlusive disease in native superficial femoral arteries and proximal popliteal arteries.
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Cook Medical is introducing five new products, which seek to treat peripheral arterial disease (PAD) and other diseases of the circulatory system.
Peripheral arterial occlusive disease is becoming an increasingly more common presentation, particularly as the population ages in the industrial world. The utilization of CT angiography (CTA) to visualize and evaluate the extent of the disease can be a more attractive option compared with the current diagnostic standard of digital subtraction angiography, which is an invasive and expensive examination.
The notion that pre-treatment imaging can improve a stroke patient's prognosis has been widely accepted; however, questions remain about which modality to use, according to data presented at the 2009 European Congress of Radiology (ECR) this week in Vienna, Austria.
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