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When ordinary is extraordinary
For stroke patients, every second counts
Kimberly Mundt woke up early for her 5 a.m. shift, like she did most weekends. Despite the pre-dawn start, she was grateful for a good night’s sleep after a headache almost spoiled dinner with her husband. Not long after the morning rush cleared at the coffee shop, Kimberly was working when she felt her arm go numb. Then her face.
An astute coworker noticed the right side of Kimberly’s face drooping and called an ambulance. Kimberly struggled to tell the emergency medical technician what she was experiencing. But after spending just a few minutes with her, the EMT knew: Kimberly Mundt was having a stroke.
An acute ischemic stroke occurs when a vessel supplying blood to the brain is obstructed, usually by a blood clot. When the blood supply is interrupted, your brain no longer gets the oxygen and nutrients it needs, causing brain cells to die by the minute.1 Clinicians who treat ischemic stroke have a saying — “time is brain”2 — to underscore the urgency of treating patients quickly. Each year, there are over 13 million cases of stroke globally,3 and minutes can make the difference between a permanent disability and a chance at full recovery.
Dr. Daniel Sahlein, an interventional neuroradiologist, received the MRI scans of Kimberly Mundt’s brain not long after she arrived at Ascension St. Vincent Hospital in Indianapolis. The images were alarming: A large clot was blocking the flow of blood to the left hemisphere, which controls speech and memory. Dr. Sahlein knew every minute mattered for Kimberly. After the surgical risks were communicated to Kimberly’s family, Dr. Sahlein chose to remove the clot with the Solitaire X™ revascularization device. “I felt confident she would regain a lot of function she lost during the event,” Dr. Sahlein said. “I felt very comfortable telling her husband that we were able to extract the entire clot and did so quickly.”
Watch Dr. Sahlein and Kimberly share more about their story.
In 2007, Distinguished Engineer Mark Ashby and his team at Medtronic were confronted with a challenge: Design a model to test how ischemic strokes occur in the brain in hopes of developing a new treatment option. At the time, patients had few effective options, especially for big clots that can’t be easily dissolved by drugs.
The engineers zeroed in on the need to relieve pressure inside the artery to ease the clot out. If the pressure was too high, the clot wouldn’t budge; they needed a way to reduce the flow of blood in the blocked artery.
So where did the team find inspiration? In the design of another Medtronic device, an implantable stent used to treat certain types of aneurysms, which works by diverting the flow of blood. But they knew they couldn’t leave the stent inside an artery; they needed a way to pull it — and the clot — out.
So they created a stent made from a super-elastic nickel-titanium alloy. Once deployed in the blocked artery via a microcatheter, the stent expands to embed into the clot and push it against the artery wall, reestablishing blood flow and relieving the pressure. Then both the clot and the stent are removed with a delivery wire. It was a breakthrough treatment for ischemic stroke patients.
Cleared by the FDA in 2012, the Solitaire™ device was designed with enhanced visibility to quickly restore the flow of blood to the brain, giving stroke patients a better chance to recover. In 2019, Medtronic launched the fourth-generation Solitaire X™.
“This device has performed so well over time that we’ve never had to overhaul its design,” said Evan Epstein, the lead engineer who has worked on every generation of the device
The day after Dr. Sahlein used Solitaire X™ to remove the clot from Kimberly’s brain, he noticed an immediate, significant improvement in her speech. Four days after that, she was discharged from the hospital.
While Kimberly’s recovery has been nothing short of remarkable, it hasn’t always been easy. When she first returned home, she struggled with speech and daily tasks like calculating her daughter’s insulin needs. But with therapy, determination, and the support of her family, Kimberly has made tremendous progress.
Today, she helps her children read the Harry Potter series and has started cooking regular family dinners. Kimberly says she’s grateful. She’s grateful her coworker recognized the signs of a stroke. And she’s grateful the paramedics transported her to a comprehensive stroke clinic where Dr. Sahlein removed the blood clot. “This life is fast,” she said. “If you don’t see or understand what you have, it’s hard to understand [what you could lose].”
This testimonial is one individual’s experience and does not provide any indication, guide, warranty, or guarantee as to the response or experience other people may have using the device. Experiences can and do vary. Please talk to your doctor about your condition and the risks and benefits of Medtronic devices.
INDICATIONS: 1. The Solitaire™ X Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset. 2. The Solitaire™ X Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. 3. The Solitaire™ X Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (<70 cc by CTA or MRA, <25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
CAUTIONS: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. Indications, contraindications, warnings and instructions for use can be viewed at www.medtronic.com/manuals.
PRECAUTIONS: The Solitaire™ X Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke. Carefully inspect the sterile package and the Solitaire™ X Revascularization Device prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components. The Solitaire™ X Revascularization Device is not to be used after the expiration date imprinted on the product label. Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labeling for indications, contraindications, warnings, precautions, and instructions for use. Operators should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible. Initiate mechanical thrombectomy treatment as soon as possible. For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset. For indication 3, users should validate their imaging analysis techniques to ensure robust and consistent results for assessing core infarct size.
CONTRAINDICATIONS: Use of the Solitaire™ X Revascularization Device is contraindicated under these circumstances. Patients with known hypersensitivity to nickel-titanium. Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the Solitaire™ X Revascularization Device. Patients with angiographic evidence of carotid dissection.
POTENTIAL COMPLICATIONS: Possible complications include, but are not limited to the following: Adverse reaction to antiplatelet/ anticoagulation agents or contrast media; air embolism; allergic reactions; arteriovenous fistula; brain edema; change in mental status; device(s) deformation, collapse, fracture or malfunction; distal embolization including to a previously uninvolved territory; hematoma and hemorrhage at puncture site; infection; inflammation; intracranial hemorrhage; ischemia; neurologic deterioration including stroke progression, stroke in new vascular territory, and death; perforation or dissection of the vessel; persistent neurological deficits; post procedure bleeding; pseudo aneurysm formation; the risk of complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia) increases as the procedure time and the number of procedures increase; thrombosis (acute and subacute); vascular occlusion; vasoconstriction (vasospasm).
WARNINGS — ALL INDICATIONS: The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice. Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Do not cause delays in this therapy. Per IV t-PA manufacturer labeling, IV t-PA should be administered within 3 hours of stroke symptom onset (IV t-PA use beyond 3 hours is not approved in the United States). Do not torque the Solitaire™ X Revascularization Device. For vessel safety, do not perform more than three recovery attempts in the same vessel using Solitaire™ X Revascularization Devices. For device safety, do not use each Solitaire™ X Revascularization Device for more than three flow restoration recoveries. For each new Solitaire™ X Revascularization Device, use a new microcatheter. Solitaire™ X Revascularization Device does not allow for electrolytic detachment. To prevent device separation: Do not oversize device. Do not recover (i.e. pull back) the device when encountering excessive resistance. Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration. Do not treat patients with known stenosis proximal to the thrombus site. This device is supplied sterile for single use only. Do not reprocess or re-sterilize. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance. If excessive resistance is encountered during the delivery of the Solitaire™ X Revascularization Device, discontinue the delivery and identify the cause of the resistance. Advancement of the Solitaire™ X Revascularizaton Device against resistance may result in device damage and/or patient injury. If excessive resistance is encountered during recovery of the Solitaire™ X Revascularization Device, discontinue the recovery and identify the cause of the resistance. Advancing the microcatheter while the device is engaged in clot may lead to embolization of debris. Do not advance the microcatheter against any resistance. Do not reposition more than two times.
WARNINGS (INDICATION 1 & 3 ONLY): The safety and effectiveness has not been established for the Solitaire™ X device to reduce disability in patients with the following: posterior circulation occlusions; more distal occlusions in the anterior circulation; large core infarct (ASPECTS ≤7). Click for complete warnings and risk information.