One year following the approval of the gemcitabine intravesical system, Joseph Jacob, MD, reflects on the expanding treatment landscape in BCG-unresponsive NMIBC.
|Articles|October 15, 2006
New Products & Services
Irvine, CA-The Cryocare CN2 System from Endocare, Inc. has received 510K clearance from the FDA. The device uses the freezing capability of nitrogen at the point between gas and liquid-"critical nitrogen"-to destroy cancerous tissue quicker and more cost-effectively than argon can, according to the manufacturer. The speed and precision of this new technology can expedite procedures, Endocare says, because it is easy to use and it delivers a colder, more powerful ice ball at the end of the probes.
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A limited market release of SpaceOAR Flex is expected to begin in the US later this year.
The PDUFA target action date is in the fourth quarter of 2026.
The approval is supported by data from the phase 3 LITESPARK-011 trial.
Pearls & Perspectives: Expanding Sexual Health Conversations Through Digital Media, With Wendy Brant
Amy Pearlman, MD, and Wendy Brant discuss building a digital audience, navigating sexual health content online, and the role of communication in relationships.
Positive safety and efficacy data from 4 clinical studies supported the CE marking.
Sandip Prasad, MD, discusses patient selection for chemoablation in recurrent LG-IR-NMIBC and considerations when counseling patients about a nonsurgical approach.
In a head-to-head RCT, Rezūm produced a 4.6-point greater IPSS improvement than combination pharmacotherapy at 1 year, according to Jean-Nicolas Cornu, MD, PhD, FEBU.
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