Marilyn Pringles is someone who loves to work, work, work! In fact, it can be hard to get her to slow down and take time off. When her family planned a vacation to a friend’s cabin in the western North Carolina mountains in November 2016, she was ready and actually looking forward to some rest and relaxation with her husband and children and her younger sister and her family.
In the weeks before her vacation, Marilyn, who was 44 at the time, began experiencing a few symptoms, which she minimized due to the chronic pain she experiences from fibromyalgia. She experienced some numbness in her left arm, and after having a brain MRI that did not find anything, the doctor assumed it was from a herniated disc in her neck. He sent her home and recommended she see a neurologist. Soon thereafter, when at a casino with her elderly mother, she suddenly lost her eyesight for about five to 10 seconds. Marilyn did not mention the episode to her mother or anyone else. Then the massive headaches started, and any “noise” began to bother her. However, she continued to work fulltime the entire following week.
Marilyn's Extended "Vacation"
Despite the symptoms she was experiencing, Marilyn was determined to go on vacation. In fact, she drove her husband and two younger sons all the way from Hollywood, Florida to North Carolina. When they arrived in North Carolina, prior to reaching the cabin, Marilyn was unable to continue driving so her husband drove the final stretch along the mountain road to Lake Toxaway. Shortly after their arrival, Marilyn collapsed and her husband found her lying face down on the patio, totally disoriented. She did not recognize him, did not know where she was or what had happened. She was screaming in a state of panic. Within a few minutes, her husband calmed her down and helped her walk upstairs to the master bedroom. Marilyn insisted she needed to use the restroom and when she looked in the mirror, she noticed her face drooping and thought she had just suffered a stroke. She immediately dialed 911 from her cellphone and EMS from the volunteer fire department came and took her to the nearest hospital in Brevard for stabilization before being airlifted to Mission Hospital in Asheville.
Upon admission to the hospital, doctors diagnosed Marilyn as having a ruptured brain aneurysm. She immediately underwent a coiling procedure to stop the rupture. In addition, as is common after a brain aneurysm, Marilyn experienced hydrocephalus, a condition in which excess spinal fluid builds up within the brain creating pressure. Doctors performed a craniotomy and implanted a shunt so the fluid would drain and relieve the pressure in her head. She remained in ICU unresponsive for 17 days. When Marilyn woke up, she had no idea where she was. She saw her brother, Juan Landrian, who explained to her what had happened. Coincidentally, Juan works for Medtronic, one of the world’s largest medical technology companies, where he is a medical science liaison for hemorrhagic stroke and well-versed in today’s treatment options for brain aneurysm. After about six weeks in the hospital, Marilyn was cleared to leave in late December. Her husband drove her back to South Florida and she was back at work on January 2, 2017.
The Road to Recovery Continues
Unfortunately, Marilyn’s recovery was short-lived. “I was really excited to be back at work so quickly and was just getting my stride back when I suffered an excruciating headache, which was later discovered to be from the area where the aneurysm had been coiled,” says Marilyn. “It turned out the aneurysm coiling had shifted; thus the coiling procedure had not completely worked.” On March 24, 2017, she was admitted to Memorial Hospital in South Florida where doctors performed a minimally invasive procedure using Medtronic’s Pipeline Embolization Device, a specialized stent implanted across the neck of the aneurysm to prevent blood flow into the aneurysm and allow the damaged blood vessel to heal.
Marilyn’s aneurysm was located in an area where brain aneurysms are uncommon and do not cause many long-term physical issues. “I was very fortunate that I didn’t need any physical, occupational or speech rehab,” says Marilyn. “The pipeline procedure was successful and my shunt is operating properly. Before all of this happened, I really didn’t understand what my brother did for a living. I was so fortunate to have his experience and knowledge throughout the entire ordeal.” The self-described workaholic continues her career as a paralegal for a personal injury defense law firm and has long list of things she continues to check off her bucket list
MEDTRONIC RECEIVES FDA APPROVAL ON EXPANDED INDICATION
FOR PIPELINE FLEX EMBOLIZATION DEVICE
(Medtronic's News Release)
Approval Based on Clinical Data from the PREMIER Trial - New Indication Provides Options for Patients with Small or Medium, Wide-Necked Brain Aneurysms
DUBLIN – February 7, 2019 – Medtronic plc (NYSE:MDT) announced today that it has received U.S. Food and Drug Administration (FDA) approval on an expanded indication for its Pipeline™ Flex embolization device.1 Previously indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments, the new indication opens options for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery.
An estimated 500,000 people throughout the world die each year due to ruptured brain aneurysms, with half the victims younger than 50 years of age.
Approval was based on clinical data from the Prospective Study on Embolization of Intracranial aneurysms with the Pipeline™ Device (PREMIER) trial, which expands
understanding of the safety and efficacy for this device for a broader patient population. A total of 141 subjects with a mean aneurysm size of 5.0±1.92 mm were analyzed. Data showed one-year occlusion rates of 76.7 percent with the use of 1.1 device per subject on average and a 2.2 percent occurrence of major stroke or neurological death.
"PREMIER is another landmark study with Pipeline and moves the bar on the safe treatment of wide-necked brain aneurysms,” said Dr. Ricardo Hanel, neurosurgeon, director of Stroke and Cerebrovascular Center at Baptist Health in Jacksonville, Fla., and principal investigator for the PREMIER trial. “This data changes the way we, as physicians, think about using Pipeline Flex to treat our patients.“ Designed to divert blood flow away from an aneurysm, the Pipeline Flex embolization device features a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm. The device cuts off blood flow to the aneurysm, reconstructing the diseased section of the parent vessel. This is the second Investigational Device Exemption (IDE) study for this implant which gained FDA approval after completing the ‘Pipeline for Uncoilable or Failed aneurysms’ (PUFs) trial, a 5-year study for large and giant wide-necked aneurysms of the intracranial internal carotid artery (ICA) where efficacy rates were
reported at 70.8 percent at 1 year that progressed to 95 percent in subjects with angiographic follow up at the 5 year time period. In the PUFs study the overall occurrence of major stroke or neurological death was 5.6 percent.
There were no documented cases of aneurysm recurrence in patients treated with the implant.
"Working hand-in-hand with physicians to develop new technology and clinical data is at the core of our mission. The PREMIER study not only demonstrated excellent safety and efficacy outcomes but also delivered on our commitment to broadening access to innovative therapies for new groups of patients requiring aneurysm treatment,” said Stacey Pugh, vice president and general manager of the Neurovascular business, which is part of the Restorative Therapies Group at Medtronic.
In the United States, the Pipeline Flex device is intended for use for the endovascular
treatment of complex wide-necked intracranial aneurysms located in the ICA, attached to parent vessels measuring between 2.0 and 5.0 mm in diameter. Flow diversion has been used to treat patients in the United States since 2011. This product is part of the Neurovascular portfolio in Medtronic's Restorative Therapies Group.
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services, and solutions companies – alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals, and patients in more than 150 countries. The company is focused on collaborating with stakeholders
around the world to take healthcare Further, Together. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange
Commission. Actual results may differ materially from anticipated results.