has announced US Food and Drug Administration approval for its Ruby XL system, which includes three coils: the Ruby XL, the POD XL and the Packing Coil XL. The Ruby XL coil is a device used in vascular embolisation, a procedure to block or close off blood vessels, and can be used to frame large aneurysms, while the POD XL is designed for use in high-flow vessels and the Packing Coil XL is designed to adjust to the shape of any vessel up to 70cm in length. All Ruby XL system coils can be delivered through a 0.035-inch diagnostic catheter. The system is expected to enable Penumbra to increase its market share in peripheral embolisation coils, according to leading data and analytics company .
According to GlobalData鈥檚 , Penumbra currently holds the majority market share for peripheral embolisation coils. Its new coil system allows for peripheral embolisation procedures to be done on a wider range of aneurysm sizes and in longer vessels. If the Ruby XL coil is widely adopted by physicians, Penumbra may be able to capture half the entire market.聽
The approval of the new coil could put a bigger gap between Penumbra and its competitors in the market. Physicians may choose Ruby XL coils for their procedures in order to gain better control of large aneurysms.
The Ruby XL system may come with cost savings for consumers as it delivers more volume per coil than other available coils. The average selling price (ASP) of these coils ranges from approximately $900 to $2,000. Already in the middle of this range with its current coils, Penumbra has a competitive advantage for new products. If they come in with a competitive ASP, Penumbra may displace competitor coils for relevant procedures.聽
Penumbra stands to maintain its market lead and possibly increase its market share as the purchasing of the Ruby XL system begins. GlobalData will continue to monitor market trends as purchasing picks up. It is expected that facilities will begin purchasing these coils in June 2025.
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By GlobalData