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# Require IDE for Vena’s MicroAngioscope: Petition
- URL: https://www.fdaweb.com/require-ide-for-venas-microangioscope-petition/
- Published: 2026-06-24T12:00:00.000Z
- Updated: 2026-09-14T13:41:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161371

Harmed Americans for Reform in Medical Device Safety, which is led by cardiac surgeon **Nooman Noorchashm**, known to FDA for his [opposition](https://www.fdaweb.com/login.php?sa=v&aid=D5142572&searchWords=Noorchashm&cate=S&stid=%241%24jy4.wy..%24A0HHPIirR1a0pf6sqbyyf) to power morcellation and for raising issues about surgical mesh, is petitioning the agency to require Vena Medical to obtain an IDE for its MicroAngioscope. The 6/22 [petition](cardiac%20surgeon%20Hooman%20Noorchashm,%20known%20to%20FDA%20for%20his%20opposition%20to%20power%20morcellation%20and%20for%20raising%20issues%20about%20surgical%20mesh.) says an IDE should also be obtained by any sponsors investigating the device’s use in neurointerventional procedures, including acute ischemic stroke thrombectomy.

The petition specifically asks that the agency:

- require the manufacturer and any sponsors studying the Vena MicroAngioscope system for neurovascular uses to apply for and obtain approval of an IDE to conduct clinical trials evaluating its safety and effectiveness;
- clarify whether neurovascular use falls within the existing label and, if it does not, issue an It Has Come to Our Attention letter to the device manufacturer; and
- require the manufacturer to conduct postmarket monitoring of the Vena MicroAngioscope.

“The Vena MicroAngioscope is a significant risk device that requires carefully regulated use and collection of data to determine whether it can be used safely and effectively in patients,” the petition says. “For example, the device is used in high-risk clinical settings to view blood vessels where patients may be in critical condition. The device is inserted into blood vessels and used to visualize potential hazards. In doing so, it requires, as stated in the manufacturer’s patent, ‘occlusion of the blood vessel\[, which\] . . . may impede blood flow through the blood vessel during such time, thereby temporarily reducing blood perfusion to brain tissue regions otherwise perfused by the unoccluded blood vessel….’”

It says the limited evidence from clinical practice suggests the risks are real.