SeaSpine Announces Full Commercial Launch of the Mariner MIS Wayfinder System
Mariner MIS Wayfinder is a novel, one step, k-wireless screw delivery system for pedicle screw fixation. Mariner MIS Wayfinder eliminates reliance on traditional guidewires for percutaneous screw placement by providing a fully integrated, surgeon-led solution that leverages the strength and versatility of SeaSpine’s foundational Mariner modular pedicle screw technology.
Mariner MIS Wayfinder is fully integrated with the 7D FLASH™ Navigation System’s recently launched FLASH Percutaneous module. FLASH Percutaneous addresses the minimally invasive spine surgery market and facilitates a fast, efficient, and simple workflow that complements Mariner MIS Wayfinder’s all-in-one modality, making it an optimal solution for MIS spinal fusion procedures.
“Thoughtful and efficient instrumentation design in Mariner MIS Wayfinder delivers the capability to significantly reduce the number of steps associated with fixation placement,” said
“Mariner MIS Wayfinder has been a powerful addition to the Mariner platform,” stated
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Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the Mariner MIS Wayfinder System providing a fully-integrated, surgeon-led solution that enables real-time feedback, providing clinicians an innovative and intuitive approach to pedicle screw fixation, providing a one-step posterior percutaneous pedicle solution that eliminates need for stepwise pedicle access trocars and guidewires, and offering access to a new level of operative efficiency. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of newly launched products, such as the Mariner MIS Wayfinder System, to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of substantial clinical validation of products in limited commercial (or “alpha”) launch; the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of delay in timely obtaining regulatory clearances; the Company’s ability to continue to invest in medical education and training for its newly launched products, including the Mariner MIS Wayfinder System; unexpected expense and delay, including as a result of developing and supporting the launch of new products; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.
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Source: SeaSpine Holdings Corporation