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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 aneurysm. [6]
Penumbra 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 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]
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 ]
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.
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.
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.
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.
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.
Cerebral angiography is a form of angiography which provides images of blood vessels in and around the brain, thereby allowing detection of abnormalities such as arteriovenous malformations and aneurysms. It was pioneered in 1927 by the Portuguese neurologist Egas Moniz at the University of Lisbon, who also helped develop thorotrast for use in the procedure.
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.
Carotid artery stenosis is a narrowing or constriction of any part of the carotid arteries, usually caused by atherosclerosis.
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.
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.
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.
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.
Acute limb ischaemia (ALI) occurs when there is a sudden lack of blood flow to a limb, within 14 days of symptoms onset. It is different from another condition which is more chronic called critical limb ischemia (CLD). CLD is the end stage of peripheral vascular disease where there is still some collateral circulation (alternate circulation pathways} that bring some blood 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.
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.
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.
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.
