FDA advisers back Cook stent for leg arteries

The device could become the first drug-coated stent to treat peripheral arteries in the U.S. market if the FDA follows the recommendation of the panel, which it is not required to do.Privately-held Cook Medical, based in Bloomington, Indiana, competes against device makers such as Boston Scientific and Covidien, which also make leg stents, in a stent market estimated at $5 billion worldwide.Stents are tiny mesh-like tubes used to prop open arteries that have been cleared of blockages from plaque, a build-up of cholesterol, fatty deposits and scar tissue.”This hasn’t really been about bringing a product to market; it’s been about bringing a new option to patients,” David Timlin, distinguished regulatory affairs advisor at Medtronic Surgical Technologies and the industry representative on the panel, said at the meeting, which was webcast.”It’s just a prime example of how things should work, especially in an environment where industry and the FDA are sometimes adversarial,” he said, echoing generally glowing reviews from panel members.The most commonly used drug-coated stents are placed in heart arteries following angioplasty procedures, when doctors open clogged arteries with an inflated balloon.The Cook Medical stent is coated with paclitaxel, an anti-cancer drug. The drug is used to help prevent re-clogging of the artery by inhibiting the growth of scar tissue.The device was approved for sale in Europe in 2009.The Zilver PTX stent is meant to treat peripheral arterialdisease, which according to the company affects about 30 million people a year. The disease develops when arteries outside the heart build up plaque, causing them to narrow and restrict blood flow.Patients with the disease may have pain when walking, sores or ulcers, or weakness in the legs. Total loss of circulation can lead to gangrene and limb amputation, although that is rare.

TEXT-Fitch cuts Andromeda Finance S.r.l. class A1 notes

EUR97.6m Class A1 notes due 2028: ‘A+’; Outlook revised to Negative from StableThe downgrade and Outlook revision reflect the reduced credit quality of SACE S.p.A - the Italian Export Credit Agency owned by the Italian government - which guarantees the project loan underlying the Class A1 notes. SACE was downgraded from ‘AA-’ to ‘A+’ on October 10, 2011 with the Outlook revised from Stable to Negative in line with the downgrade and Outlook revision of Italy’s sovereign rating on October 7, 2011. The rating and the Outlook on the Class A1 notes of Andromeda Finance S.r.l. are aligned with those of SACE given the structural features of the guarantee.The rating on the Class A2 notes, which rank pari passu with Class A1 but do not benefit from the SACE guarantee, and the underlying rating on the Class A1 notes, are unaffected and remain ‘BB+’ with Stable Outlook.The transaction is a securitisation of two project loans (Facility A1 and Facility A2) under law 130/99 (the Italian securitisation law). The debt facilities were extended by BNP Paribas and Societe Generale to Andromeda PV S.r.l. (the project company) to build and operate two photovoltaic (PV) plants of 45.1MW and 6.1 MW (a total 51.2MW) in Montalto di Castro, Italy. The terms of the loans effectively mirror those of the rated notes, with payments under Facility A1 and Facility A2 servicing the Class A1 notes and Class A2 notes, respectively.