Shots:
- The US FDA has granted 510(k) clearance to the Transseptal Puncture Device to advance minimally invasive access for left-heart procedures, with plans to begin US commercialization
- The Device is a next-gen system enabling zero-exchange access to the left heart, integrating RF guidewire tech with standard electrosurgical generators & an echogenic, extendable atraumatic probe to enhance visualization & precision
- In a first-in-human study (n=5), the device achieved 100% procedural success with no device-related adverse events, along with minimal crossing time & reduced fluoroscopic exposure
Ref: PRnewswire | Image: ProtaryxMedical | Press Release
Related News: Miracell Reports US FDA 510(k) Clearance for SMART M-CELL PRP and Bone Marrow Concentration Systems
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