Boston Scientific has earned a CE Mark for its disposable Exalt Model D for endoscopic retrograde cholangiopancreatography procedures. The single use duodenoscope received 510(k) approval from the FDA in December as a breakthrough device.
The company plans a limited market release in Europe during the first quarter of 2020, beginning in Germany, France, Italy, the UK and Sweden. The product will be available to hospitals as an alternative to reusable duodenoscopes.
The single-use design means the device does not need to undergo repairs or reprocessing and ensures a new, sterile device is used in every procedure.