Company Overview
Snapshot
Founded in November 2013, Transseptal Solutions operates with 1–10 employees. The company achieved a significant milestone in October 2018 by securing FDA 510(k) clearance for its TSP Crosser transseptal access system, expanding its market reach for left atrium access procedures.
Business overview
Transseptal Solutions is a Health Tech & Life Sciences company focused on improving left-atrium-access procedures. The company develops a steerable sheath system for transseptal puncture and left atrium navigation, designed to enhance safety and precision in cardiac treatments. Its core product, the CE-marked and FDA-approved TSP Crosser, is an integrated transseptal system that facilitates accurate engagement of the fossa ovalis and serves as a guiding catheter for various left-side procedures, including transcatheter mitral repair/replacement, PVL closure, atrial fibrillation ablation, and left-atrial appendage occlusion. Transseptal Solutions primarily serves the healthcare industry, targeting providers with its medical device solutions.
Strategic signal
In November 2021, Transseptal Solutions' products were highlighted by Biotronik's New Dimension platform as crucial tools for arrhythmia treatment, specifically noting the variety of fixed and bidirectional deflectable sheaths and corresponding needles for transseptal puncture. This signals ongoing industry recognition and integration of Transseptal Solutions' technology within broader cardiovascular treatment ecosystems, indicating continued relevance and potential for strategic partnerships or adoption in the medical device market.
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- What is Transseptal Solutions' primary product?
- Transseptal Solutions' primary product is the TSP Crosser, an integrated transseptal system that includes a method to engage the fossa ovalis precisely and efficiently using an extendable radiopaque loop wire and a steerable sheath for accurate left-atrium access.
- When did Transseptal Solutions announce the first clinical use of its TSP Crosser in the United States?
- In June 2019, Transseptal Solutions announced the first clinical use of its TSP Crosser in the United States, with the procedure successfully performed at the Montefiore-Einstein Center for Heart and Vascular Care.
- What regulatory clearances has Transseptal Solutions received for its TSP Crosser?
- Transseptal Solutions received FDA 510(k) clearance for its TSP Crosser transseptal access system in October 2018. The device had previously received CE Mark approval in the European Union.
- What is the strategic importance of the TSP Crosser's FDA clearance?
- The FDA clearance of the TSP Crosser in October 2018 was a significant step for Transseptal Solutions, enabling the company to address the growing global demand for trans-septal catheter interventions for patients with structural heart disease in the US market.
- What types of medical procedures does the TSP Crosser support after puncture?
- After transseptal puncture, the TSP Crosser's steerable sheath serves as a guiding catheter for various left-side procedures, including transcatheter mitral repair/replacement, PVL closure, atrial fibrillation ablation, and left-atrial appendage occlusion.