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- Company Receives CE Mark Approval for Non-Compliant Balloon That Provides Controlled Strength and Superb Deliverability OrbusNeich today announced the addition of the Sapphire NC coronary dilatation catheter to its product line-up with the receipt of CE Mark approval. A non-compliant balloon, Sapphire NC has controlled growth of only 0.6% per atmosphere of pressure over the working pressure range for controlled dilatations. Furthermore, it has a high 22 atmospheres rated burst pressure for confident treatment of tough, calcified lesions and for post-stent dilatation. "Sapphire NC is a relia...