Angeion Receives Approval To Market New ICD and Lead Systems

Angeion Corp. has received Premarket Approval (PMA) from FDA for the U.S. market release of its Lyra 2020 Series of implantable cardioverter defibrillators (ICD), and its AngePass 4040 and 4080 lead systems. The PMA triggers a $10 million equity investment from Angeion's marketing partner, Synthelabo, $5 million for the approval of the Lyra and $5 million for the approval of the AngePass leads.

The Lyra 2020 Series of ICDs is designed to provide value to the patient and physician in terms of patient comfort, reduced trauma and ease of implant. The 2020 represents one of the smallest ICDs implanted to date with a volume of only 47 cc and weight of 88 g. Offering an elongated, rounded-edge shape to accommodate a smaller incision, the Lyra is designed to improve implantation and long-term patient comfort. With a projected device longevity of 8-9 years and diagnostic capabilities of one full hour of programmable stored electrograms for later retrieval and analysis, the Lyra Series is Angeion's most advanced product to date in its pipeline of arrhythmia products.