The U.S. Meals and Drug Administration cleared the Penumbra JET 7 Reperfusion Catheter with Xtra Flex know-how (Jet 7 Xtra Flex) on the market by 510(okay) premarket notification in June 2019. FDA cleared the JET 7MAX configuration, which incorporates the JET 7 Xtra Flex catheter and MAX Supply System, on the market in February 2020.
The Penumbra Jet 7 Xtra Flex Catheter and JET 7MAX configuration are a part of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing. Docs use these units to carry out a direct aspiration mechanical thrombectomy — a process that removes blood clots from blood vessels in stroke sufferers by vacuuming out the clot.
Docs can use the Jet 7 Further Flex Catheter to take away blood clots in stroke sufferers inside eight hours of stroke symptom onset.
The Jet 7 Further Flex Catheter is particularly to be used in sufferers who are suffering an acute ischemic stroke who usually are not eligible for or didn’t reply to clot busting medicine referred to as t-PAs.
Clinical trials have proven that mechanical thrombectomy works higher than remedy with clot busting medicine for stroke sufferers who are suffering giant vessel clots, in response to a 2020 meta-analysis printed by Pavlos Texakalidis and colleagues in Neurosurgery.
How Does the Jet 7 Catheter Work?
The Jet 7 Xtra Flex Catheter is a big diameter, single use, versatile catheter with a information wire. It attaches to plastic tubing and an aspiration pump. The pump acts like a vacuum. The Xtra Flex know-how was designed as an development to its Penumbra Jet 7 Reperfusion Catheter with Customary Tip.
Docs insert the catheter by an artery within the groin, up by the neck and to the placement of the blood clot inflicting the stroke. They use fluoroscopy, or steady x-ray, to watch the progress of the catheter because it travels by the artery.
As soon as the catheter reaches the blood clot, it sucks out the clot. This unblocks the blood vessel and restores blood circulate. Docs then information the catheter again out of the physique.
Legal professionals are investigating Jet 7 Xtra Flex Catheter lawsuits on behalf of stroke victims injured by the gadget. Be taught extra about pending litigation.
Facet Results and Issues
Unwanted effects and issues linked to the Jet 7 Xtra Flex Catheter embody device-related issues and unwanted side effects from fluoroscopy. These vary from allergic reactions to elevated threat of cancer from X-ray publicity, in response to the chance data supplied by Penumbra.
The chance data doesn’t specify how frequent unwanted side effects are. Sufferers ought to focus on dangers with their medical supplier.
Potential Jet 7 Xtra Flex Catheter hostile occasions embody:
- Allergic response and anaphylaxis from distinction media
Acute occlusion (blockage)
Air embolism (blockage in artery)
Arteriovenous fistula (irregular connection between artery and vein)
Distal embolization (blockage in a coronary artery due to clot, damaged guidewire or air)
Emboli (blood clot, air bubble, fatty deposit or different object that may lodge in a blood vessel)
False aneurysm formation (leaking blood in tissues surrounding an injured blood vessel)
Bruising or hemorrhage at entry website
Lack of ability to fully take away blood clot
Ischemia (insufficient blood provide to part of the physique or organ)
Kidney harm from distinction media utilized in fluoroscopy
Neurological deficits together with stroke
Thrombosis (blood clot)
Dissection or perforation of blood vessels
Radiation publicity that will result in cataracts, pores and skin reddening, burns or alopecia
Most cancers from x-ray publicity
Recall and Lawsuits
Penumbra recalled greater than 30,000 Jet 7 Xtra Flex units on Dec. 15, 2020. This recall doesn’t have an effect on Penumbra Jet 7 Reperfusion Catheter with Customary Tip.
“Penumbra is recalling the JET 7 Xtra Flex as a result of the catheter might change into prone to distal tip harm throughout use. Distal tip harm at the side of pressurization or distinction injection might lead to potential vessel harm, and subsequent affected person damage or loss of life,” in response to the corporate’s Urgent Voluntary Medical Device Recall Notification.
On the time of the recall, Penumbra mentioned it was conscious of 17 affected person accidents and 14 deaths attributed to catheter tip harm, and growth and rupture following distinction injection.
Shortly after the U.S. Meals and Drug Administration introduced the recall, legal professionals started investigating Jet 7 Xtra Flex Catheter lawsuits on behalf of stroke victims injured by the gadget.
Please search the recommendation of a medical skilled earlier than making well being care choices.
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