Client
Overview
Xenter is at the forefront of medtech innovation, advancing medical devices, digital health technologies, and imaging to transform patient care. With a focus on enabling AI-driven clinical decision support through smart, connected devices, Xenter is reimagining how real-time data can be leveraged to enhance patient outcomes.
The company’s mission is to develop devices and digital tools that bring precision and intelligence to minimally invasive cardiovascular procedures.
Challenge
Xenter’s pioneering dual-sensor guidewire, the TAVR SmartWire, is designed to redefine data collection during transcatheter aortic valve replacement (TAVR) procedures. By collecting physical intelligence data, this investigational guidewire aims to become a clinical decision-support tool, enabling accurate measurement of aortic regurgitation (xAR) and improving para valvular leak (PVL) prediction.
To successfully deploy the SmartWire, Xenter needed a digital platform that could:
Seamlessly Connect Devices and Data
Capture and transmit data from the wireless guidewire to clinicians, providing insights during procedures.
Operate Within a Wireless Ecosystem
Ensure interoperability within Xenter’s wireless ecosystem, interfacing smoothly with hospital EHR systems and clinical workflow tools.
Scale for Clinical Research and Commercialization
Establish a platform capable of supporting clinical evaluations, real-world applications, and future innovations in cardiovascular medicine.
SOLUTIONS
Pi Tech’s Specless Engineering approach was perfectly suited to Xenter’s dynamic, evolving needs. This methodology, which thrives on flexibility and a focus on high-level objectives rather than rigid specifications, allowed Pi Tech to rapidly develop a sophisticated digital platform that aligned with Xenter’s vision for precision-guided cardiovascular procedures.
Developed a real-time data interface to capture and display metrics like aortic and left ventricular pressure, enabling quick, actionable insights for clinicians during TAVR procedures.
Built the platform to be “AI-ready,” supporting advanced analytics to transform data into predictive insights for clinical decision-making without disrupting existing workflows.
Implemented HIPAA-compliant, role-based access to ensure secure handling of sensitive health data. The platform integrates with hospital EHRs for seamless clinical workflows.
Utilized API mocks and simulated device behavior using hardware modules to expedite development, ensuring platform readiness while Xenter’s backend systems evolved.
Ensured that the platform met stringent data security standards, adhering to HIPAA regulations and FDA requirements for medical device software, laying the foundation for the 510(k) submission.
Results
The SmartWire transmits real-time data, providing cardiologists with crucial insights into aortic and ventricular pressures during TAVR procedures and supporting better predictions of aortic regurgitation.
The SmartWire transmits real-time data, providing cardiologists with crucial insights into aortic and ventricular pressures during TAVR procedures and supporting better predictions of aortic regurgitation.
The SmartWire transmits real-time data, providing cardiologists with crucial insights into aortic and ventricular pressures during TAVR procedures and supporting better predictions of aortic regurgitation.
Technologies Used
Frontend
React Native (iOS & Android), React (web)
