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Penumbra (medical company)

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Penumbra, Inc. is a medical device company[1][2] headquartered in Alameda, California.[3][4] The company was founded by Arani Bose and Adam Elsesser in 2004.[5] It manufactures devices for interventional therapies to treat vascular conditions such as stroke and aneurism.[6]

History

Penumbra initially focused on treatments for ischemic stroke.[7] In 2015 the company issued an IPO on the NYSE.[8] In 2018 the company acquired 40% of the outstanding shares of virtual reality joint venture MVI Health.[9][10] In 2017 the company acquired the Italian distributor Crossmed.[11][12][excessive citations]

Criticism of Penumbra

Criticism of Penumbra has followed various aspects of its products and business practices. In 2016 a lawsuit claimed the Penumbra Coil 400 caused brain damage after surgery.[13] The company's specialized catheter has been linked to the deaths of stroke patients, and it was a target of stock short sellers in 2020.[14][15][16][excessive citations] According to the Foundaiton for Financial Journalism this is a significant dilemma.[17]

A request has been sent to The SEC and U.S. Food and Drug Administration launch an investigation.[18] A scientist who has published research articles showing the reliability of Penumbra's medical products is (allegedly) an internet fabrication.[19]

Recalls

In 2011 the company recalled its Penumbra Coil 400.[20] In 2017 the company recalled a 3D revascularization device.[21] In 2020 the company recalled one of its catheter used during heart surgery due increased risk of mortality and serious injury.[22][23][24][excessive citations]

References

  1. ^ "Penumbra Company Profile". Bloomberg.
  2. ^ "Penumbra Company Profile". Reuters.
  3. ^ "Big Penumbra expansion in Alameda". East Bay Times. Retrieved 23 December 2020.
  4. ^ AVALOS, GEORGE (February 3, 2020). "Penumbra picks new site for East Bay headquarters". East Bay Times. Retrieved 15 December 2020.
  5. ^ "Penumbra Inc (NYSE:PEN)". CNN.
  6. ^ "Penumbra Company Profile". Reuters.
  7. ^ Fink, Victoria. "This Innovative Startup Is Transforming the Way Doctors Treat Stroke PatientsThis medical-device startup wants to transform health care". Inc. FROM THE APRIL 2016 ISSUE OF INC. MAGAZINE. Retrieved 23 December 2020.
  8. ^ Primack, Dan. "Penumbra goes public tomorrow. Hear from its CEO today". Fortune. Retrieved 29 December 2020.
  9. ^ Fink, Charlie. "Sixense Focused On VR's Killer App". Forbes. Retrieved 28 December 2020.
  10. ^ DENSFORD, FINK (2018). "Penumbra acquires 90% interest in MVI Health JV, launches thrombectomy devices". Mass Device.
  11. ^ "Penumbra picks up Italian distributor Crossmed for $9m". Mass Device. July 2017.
  12. ^ "PENUMBRA, INC. UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION". Securities and Exchange Commission. Retrieved 28 December 2020.
  13. ^ Bellisle, Martha (March 26, 2016). "Lawsuit claims medical device caused brain damage after Bellevue surgery". The Associated Press.
  14. ^ Farrell, Greg; Fineman, Joshua (December 9, 2020). "Catheter-Linked Death Jolts Penumbra, a Target of Short Sellers". Bloomberg (via Yahoo Finance).
  15. ^ "Fake Author Allegation Spurs Drop in Catheter Maker Penumbra". Bloomberg. Retrieved 23 December 2020.
  16. ^ Baker, Nathaniel (Nov 18, 2020). "Short-Sellers Grego, Cohodes Take Aim At Penumbra". Forbes.
  17. ^ Boyd, Roddy. "Penumbra Inc.'s Catheter Fail: Broken Tips and Lost Lives". Foundation for Financial Journalism. Institute for Nonprofit News. Retrieved 29 December 2020.
  18. ^ Stankiewicz, Kevin (Dec 8, 2020). "Shares of medical device maker Penumbra tank after short seller releases critical report". CNBC. Retrieved 15 December 2020.
  19. ^ Farrell, Greg; Fineman, Joshua (December 9, 2020). "'Fake' Author Rap Sinks Shares of Catheter-Maker Penumbra". Bloomberg (via Yahoo Finance). Retrieved 15 December 2020.
  20. ^ Pedersen, Amanda (July 24, 2017). "Risk of Wire Breakage Prompts Penumbra Recall". Medical Device + Diagnostic Industry (MD+DI). Retrieved 23 December 2020.
  21. ^ "Penumbra Inc. Recalls 3D Revascularization Device Due to Wire Material That May Break or Separate During Use". U.S. Food and Drug Administration. Retrieved 23 December 2020.
  22. ^ "Penumbra recalls JET 7 catheters with Xtra Flex technology". Neuro News. December 18, 2020.
  23. ^ "Penumbra's Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers". U.S. Food and Drug Administration. Retrieved 23 December 2020.
  24. ^ Wood, Shelley (December 16, 2020). "FDA: Penumbra JET 7 Clot Retrievers Recalled Following Deaths, Injuries". Cardiovascular Research Foundation.
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