Penumbra (medical company)

Last updated
Penumbra
Company type Public company
NYSE:  PEN
Industry Medical supplies
Founded2004;20 years ago (2004)
FounderArani Bose and Adam Elsesser
Headquarters
Alameda, CA
,
United States
Area served
Worldwide
Key people
Adam Elsesser (CEO)
Products Medical devices
Number of employees
4,200 (2024)
Website www.penumbrainc.com

Penumbra, Inc. is an American medical device company headquartered in Alameda, California. [1] [2] [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 aneurysm. [6]

Contents

History

Penumbra was founded in 2004 and manufactures several medical devices but specializes in the neuro/vascular market and creates devices that help treat aneurysms and ischemic stroke. [7] [8]

In 2014, Penumbra launched its Apollo system, a device that “enables minimally invasive removal of deeply seated tissue and fluids in the brain,” allowing for otherwise inoperable blood clots to be removed. [9] [10]

In 2015 the company issued an IPO on the NYSE. [11] In 2018 the company acquired 40% of the outstanding shares of virtual reality joint venture MVI Health. [12] In 2017 the company acquired the Italian distributor Crossmed. [13]

Criticism

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. [14] 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. [15] [16] [17] [ excessive citations ] According to the Foundation for Financial Journalism, this is a significant dilemma. [18]

A request has been sent to The SEC and U.S. Food and Drug Administration to launch an investigation. [19] A scientist who has published research articles showing the reliability of Penumbra's medical products is (allegedly) an internet fabrication. [20]

Recalls

In 2011 the company recalled its Penumbra Coil 400. [21] In 2017 the company recalled a 3D revascularization device. [22] In 2020 the company recalled one of its catheter used during heart surgery due to increased risk of mortality and serious injury. [23] [24] [25] [ excessive citations ]

Related Research Articles

<span class="mw-page-title-main">Aneurysm</span> Bulge in the wall of a blood vessel

An aneurysm is an outward bulging, likened to a bubble or balloon, caused by a localized, abnormal, weak spot on a blood vessel wall. Aneurysms may be a result of a hereditary condition or an acquired disease. Aneurysms can also be a nidus for clot formation (thrombosis) and embolization. As an aneurysm increases in size, the risk of rupture, which leads to uncontrolled bleeding, increases. Although they may occur in any blood vessel, particularly lethal examples include aneurysms of the circle of Willis in the brain, aortic aneurysms affecting the thoracic aorta, and abdominal aortic aneurysms. Aneurysms can arise in the heart itself following a heart attack, including both ventricular and atrial septal aneurysms. There are congenital atrial septal aneurysms, a rare heart defect.

<span class="mw-page-title-main">Interventional radiology</span> Medical subspecialty

Interventional radiology (IR) is a medical specialty that performs various minimally-invasive procedures using medical imaging guidance, such as x-ray fluoroscopy, computed tomography, magnetic resonance imaging, or ultrasound. IR performs both diagnostic and therapeutic procedures through very small incisions or body orifices. Diagnostic IR procedures are those intended to help make a diagnosis or guide further medical treatment, and include image-guided biopsy of a tumor or injection of an imaging contrast agent into a hollow structure, such as a blood vessel or a duct. By contrast, therapeutic IR procedures provide direct treatment—they include catheter-based medicine delivery, medical device placement, and angioplasty of narrowed structures.

<span class="mw-page-title-main">Ischemia</span> Restriction in blood supply to tissues

Ischemia or ischaemia is a restriction in blood supply to any tissue, muscle group, or organ of the body, causing a shortage of oxygen that is needed for cellular metabolism. Ischemia is generally caused by problems with blood vessels, with resultant damage to or dysfunction of tissue i.e. hypoxia and microvascular dysfunction. It also implies local hypoxia in a part of a body resulting from constriction.

<span class="mw-page-title-main">Thrombolysis</span> Breakdown (lysis) of blood clots formed in blood vessels, using medication

Thrombolysis, also called fibrinolytic therapy, is the breakdown (lysis) of blood clots formed in blood vessels, using medication. It is used in ST elevation myocardial infarction, stroke, and in cases of severe venous thromboembolism.

<span class="mw-page-title-main">Interventional cardiology</span> Catheter-based treatment of structural heart diseases

Interventional cardiology is a branch of cardiology that deals specifically with the catheter based treatment of structural heart diseases. Andreas Gruentzig is considered the father of interventional cardiology after the development of angioplasty by interventional radiologist Charles Dotter.

<span class="mw-page-title-main">Medtronic</span> Irish tax-registered medical device company

Medtronic plc is an American-Irish medical device company. The company's operational and executive headquarters are in Minneapolis, Minnesota, and its legal headquarters are in Ireland due to its acquisition of Irish-based Covidien in 2015. While it primarily operates in the United States, it operates in more than 150 countries and employs over 90,000 people. It develops and manufactures healthcare technologies and therapies. It is one of the biggest medical tech companies in the world and is currently the largest medical device company in the world by revenue.

Mechanical thrombectomy, or simply thrombectomy, is the removal of a blood clot (thrombus) from a blood vessel, often and especially endovascularly as an interventional radiology procedure called endovascular thrombectomy (EVT). It thus contrasts with thrombolysis by thrombolytic medications, as either alternative or complement thereto. It is commonly performed in the cerebral arteries as treatment to reverse the ischemia in some ischemic strokes. Open vascular surgery versions of thrombectomy also exist. The effectiveness of thrombectomy for strokes was confirmed in several randomised clinical trials conducted at various medical centers throughout the United States, as reported in a seminal multistudy report in 2015.

<span class="mw-page-title-main">Valley Hospital Medical Center</span> Hospital in Nevada, United States

Valley Hospital Medical Center is a for-profit hospital owned by Universal Health Services and operated by Valley Health System. It is one of six hospitals within the Valley Health System in Las Vegas, Nevada. It is accredited by the Joint Commission and includes a certified Primary Stroke Center, an accredited Chest Pain Center and a certified Heart Failure Center.

A vascular bypass is a surgical procedure performed to redirect blood flow from one area to another by reconnecting blood vessels. Often, this is done to bypass around a diseased artery, from an area of normal blood flow to another relatively normal area. It is commonly performed due to inadequate blood flow (ischemia) caused by atherosclerosis, as a part of organ transplantation, or for vascular access in hemodialysis. In general, someone's own vein (autograft) is the preferred graft material for a vascular bypass, but other types of grafts such as polytetrafluoroethylene (Teflon), polyethylene terephthalate (Dacron), or a different person's vein (allograft) are also commonly used. Arteries can also serve as vascular grafts. A surgeon sews the graft to the source and target vessels by hand using surgical suture, creating a surgical anastomosis.

<span class="mw-page-title-main">Watershed stroke</span> Medical condition

A watershed stroke is defined as a brain ischemia that is localized to the vulnerable border zones between the tissues supplied by the anterior, posterior and middle cerebral arteries. The actual blood stream blockage/restriction site can be located far away from the infarcts. Watershed locations are those border-zone regions in the brain supplied by the major cerebral arteries where blood supply is decreased. Watershed strokes are a concern because they comprise approximately 10% of all ischemic stroke cases. The watershed zones themselves are particularly susceptible to infarction from global ischemia as the distal nature of the vasculature predisposes these areas to be most sensitive to profound hypoperfusion.

<span class="mw-page-title-main">Fibromuscular dysplasia</span> Human arterial disease

Fibromuscular dysplasia (FMD) is a non-atherosclerotic, non-inflammatory disease of the blood vessels that causes abnormal growth within the wall of an artery. FMD has been found in nearly every arterial bed in the body, although the most commonly affected are the renal and carotid arteries.

Dr. Thomas J. "Tom" Fogarty is an American surgeon and medical device inventor. He is best known for the invention of the embolectomy catheter, which revolutionized the treatment of blood clots (embolus).

Embolectomy is the emergency interventional or surgical removal of emboli which are blocking blood circulation. It usually involves removal of thrombi, and is then referred to as thromboembolectomy or thrombectomy. Embolectomy is an emergency procedure often as the last resort because permanent occlusion of a significant blood flow to an organ leads to necrosis. Other involved therapeutic options are anticoagulation and thrombolysis.

<span class="mw-page-title-main">Bard (company)</span> Pharmaceutical company

C. R. Bard, Inc., headquartered in Murray Hill, New Jersey, USA, was a developer, manufacturer, and marketer of medical technologies in the vascular medicine, urology, oncology, and surgical specialty fields. C. R. Bard marketed its products and services worldwide to hospitals, individual health care professionals, extended care facilities, and alternate site facilities. An S&P 500 company with approximately 14,000 employees in 2015, Bard is perhaps best known for having introduced the Foley catheter in 1934.

<span class="mw-page-title-main">Acute limb ischaemia</span> Occurs when there is a sudden lack of blood flow to a limb

Acute limb ischaemia (ALI) occurs when there is a sudden lack of blood flow to a limb within 14 days of symptoms onset. On the other hand, when the symptoms exceed 14 days, it is called critical limb ischemia (CLI). CLI is the end stage of peripheral vascular disease where there is still some collateral circulation that bring some blood flow to the distal parts of the limbs. While limbs in both acute and chronic limb ischemia may be pulseless, a chronically ischemic limb is typically warm and pink due to a well-developed collateral artery network and does not need emergency intervention to avoid limb loss, whereas ALI is a vascular emergency.

<span class="mw-page-title-main">Hybrid cardiac surgery</span>

A hybrid cardiac surgical procedure in a narrow sense is defined as a procedure that combines a conventional, more invasive surgical part with an interventional part, using some sort of catheter-based procedure guided by fluoroscopy imaging in a hybrid operating room (OR) without interruption. The hybrid technique has a reduced risk of surgical complications and has shown decreased recovery time. It can be used to treat numerous heart diseases and conditions and with the increasing complexity of each case, the hybrid surgical technique is becoming more common.

Y. Pierre Gobin is a French-born American physician who specializes in interventional neuroradiology and endovascular treatment of cerebral aneurysms. He is one of the inventors of the Concentric MERCI Retriever, a device for removing blood clots in the brain that cause stroke.

<span class="mw-page-title-main">MERCI Retriever</span>

The MERCI Retriever is a medical device designed to treat Ischemic Strokes. The name is an acronym for Mechanical Embolus Removal in Cerebral Ischemia. Designed by University of California, Los Angeles in 2001, MERCI was the first device approved in the U.S. to remove blood clots in patients who had acute brain ischemia.

<span class="mw-page-title-main">B. K. Misra</span> Neurosurgeon

Dr. Basant Kumar Misra is a neurosurgeon specialising in treating brain, spine, cerebrovascular and peripheral nervous system disorders, injuries, pathologies and malformations. He is the Vice-President of the World Federation of Neurosurgical Societies, and the former President of the Asian Australasian Society of Neurological Surgeons, and the Neurological Society of India. He is a recipient of Dr. B. C. Roy Award, the highest medical honour in India.

References

  1. ↑ "Penumbra Company Profile". Bloomberg.
  2. ↑ "Penumbra Company Profile". Reuters.
  3. ↑ "Big Penumbra expansion in Alameda". East Bay Times. 3 February 2020. 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. ↑ "Penumbra - A Cheap Medical Device Company With Growth Potential (NYSE:PEN) | Seeking Alpha". seekingalpha.com. 16 September 2015. Retrieved 2022-11-07.
  9. ↑ "Penumbra announces launch of Apollo system". NS Medical Devices. 2014-07-04. Retrieved 2022-11-10.
  10. ↑ Admin. "The Apollo™ System". Altair Health. Retrieved 2022-11-10.
  11. ↑ Primack, Dan. "Penumbra goes public tomorrow. Hear from its CEO today". Fortune. Retrieved 29 December 2020.
  12. ↑ DENSFORD, FINK (2018). "Penumbra acquires 90% interest in MVI Health JV, launches thrombectomy devices". Mass Device.
  13. ↑ "Penumbra picks up Italian distributor Crossmed for $9m". Mass Device. July 2017.
  14. ↑ Bellisle, Martha (March 26, 2016). "Lawsuit claims medical device caused brain damage after Bellevue surgery". The Associated Press.
  15. ↑ Farrell, Greg; Fineman, Joshua (December 9, 2020). "Catheter-Linked Death Jolts Penumbra, a Target of Short Sellers". Bloomberg (via Yahoo Finance).
  16. ↑ "Fake Author Allegation Spurs Drop in Catheter Maker Penumbra". Bloomberg. Retrieved 23 December 2020.
  17. ↑ Baker, Nathaniel (Nov 18, 2020). "Short-Sellers Grego, Cohodes Take Aim At Penumbra". Forbes.
  18. ↑ Boyd, Roddy. "Penumbra Inc.'s Catheter Fail: Broken Tips and Lost Lives". Foundation for Financial Journalism. Institute for Nonprofit News. Retrieved 29 December 2020.
  19. ↑ Stankiewicz, Kevin (Dec 8, 2020). "Shares of medical device maker Penumbra tank after short seller releases critical report". CNBC. Retrieved 15 December 2020.
  20. ↑ Farrell, Greg; Fineman, Joshua (December 9, 2020). "'Fake' Author Rap Sinks Shares of Catheter-Maker Penumbra". Bloomberg (via Yahoo Finance). Retrieved 15 December 2020.
  21. ↑ Pedersen, Amanda (July 24, 2017). "Risk of Wire Breakage Prompts Penumbra Recall". Medical Device + Diagnostic Industry (MD+DI). Retrieved 23 December 2020.
  22. ↑ "Penumbra Inc. Recalls 3D Revascularization Device Due to Wire Material That May Break or Separate During Use". U.S. Food and Drug Administration. Retrieved 20 March 2023.
  23. ↑ "Penumbra recalls JET 7 catheters with Xtra Flex technology". Neuro News. December 18, 2020.
  24. ↑ "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.
  25. ↑ Wood, Shelley (December 16, 2020). "FDA: Penumbra JET 7 Clot Retrievers Recalled Following Deaths, Injuries". Cardiovascular Research Foundation.
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