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Medtronic Stent Graft | Thoracic Aortic Aneurysm (TAA)

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An endovascular stent graft is like having a small, metal scaffold inside your aorta. The Valiant thoracic stent graft is indicated for exclusion of the aneurysm, the false lumen or site of rupture, and restoration of blood flow . Bench test results may not be indicative of clinical performance.AAA stent graft system. The Endurant ® II AAA Stent Graft System is designed to treat abdominal aortic aneurysms using a minimally invasive procedure called endovascular stent grafting. The Medtronic Dissection Trial 2 was designed to evaluate the safety and effectiveness of the Valiant thoracic stent graft in the treatment of acute, complicated Type B dissection, as determined by all-cause mortality within 30 days of the index procedure, compared to a performance goal based on TEVAR and open surgical repair outcomes. (One patient presented with a type Ia at their 30-day follow-up, self-resolved) 100% three-year FF secondary procedures to treat type Ia.

Aneurysm Sac Regression

Aortic neck diameters with a range of 19 to 32 mm. ENCHANT is a multicentre, prospective, single-arm, post-market study to assess the clinical outcomes, safety, and performance of the Endurant II/IIs system used with balloon-expandable covered stents for treatment of juxtarenal aortic .

Aortic Stent Grafts

Endovascular Aortic Repair (EVAR) EVAR of the abdominal aorta is performed using an AAA stent graft. In many cases, patients can return home and . The Heli-FX EndoAnchor System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented . Choose the AAA proven solution as varied as your patients.Right after the surgery, you will probably feel tired.You can address sac regression with Endurant™ II/IIs Stent Graft System. Your information will be used and protected in accordance with our privacy statement (opens new window). Dissection Case Planning. Indications, Safety, and Warnings.

Coronary Stents

Radiopaque marker band. Endurant™ stent graft systems. Your doctor may require you to lie flat for 4 to 6 hours to allow the leg wounds to begin healing.The Medtronic Micro-Driver Coronary Stent Systems are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions with reference vessel diameters of 2. The Heli-FX EndoAnchor system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation .

Reliant

Hier sollte eine Beschreibung angezeigt werden, diese Seite lässt dies jedoch nicht zu. Explore our robust percutaneous coronary intervention (PCI) portfolio and discover the stent technologies we’re bringing to patients in need.Always talk with your doctor about diagnosis and treatment information. It is a flexible wire frame (stent) sewn onto a specially woven fabric tube (graft) that physicians use to create a new path for blood flow in the patient’s aorta, reducing pressure on the . In some cases, patients can return home and return to normal activities within 4 to . You may experience side effects such as swelling of the upper thigh .Proximal neck length of ≥10 mm. The Heli-FX EndoAnchor system is intended to provide fixation and sealing between endovascular aortic grafts and the native artery.

Thoracic Aortic Aneurysm (TAA)

Endurant AAA Stent Graft System

The Endurant II stent graft system aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. Hydrophilic coating.Weitere Informationen AAA stent graft system. The Endurant™ II system family of products provides the standard of care with a legacy of clinical success for the treatment of abdominal aortic aneurysm (AAA). The delivery catheter is then withdrawn and removed, leaving the stent graft within the aorta.The Valiant Navion ™ thoracic stent graft system is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having the appropriate anatomy including: nonaneurysmal aortic distal neck length ≥ 20 mm for FreeFlo and CoveredSeal configurations for fusiform and saccular aneurysms/penetrating ulcers. Joseph Bavaria. We wish to thank the following surgeons for sharing their answers to questions about dissection treatment: Dr. ENGAGE OUS Registry: 10 years of evidence with longest-term follow-up of any global EVAR registry. The Heli-FX™ EndoAnchor™ system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom .75 mm and ≤21 mm in length. The Heli-FX™ EndoAnchor™ System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery.Resolute Onyx DES.

Endovascular stent graft therapy is a minimally invasive surgical procedure. Coding reference (. It reinforces the wall of the thoracic aorta to prevent the aneurysm from rupturing. 4 Endurant ™ II/IIs. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow wi thin the patient’s vasculature. Always talk with your doctor about diagnosis and treatment information. Resolute Onyx™ DES features a single wire design, a platinum-iridium core, and a broad diameter range. Over time, this bulge can become weak and the force of normal blood pressure can cause it to rupture.

Iliac diameters with a range of 8 to 25 mm. Endurant ™ II/IIs system product code description. Depending on the shape and size of your .pdf) (opens new window) Resources to assist with coding, coverage, and reimbursement for Medtronic Cardiovascular therapies: c-codes and resources for aortic, coronary, endovenous, peripheral arterial, and structural heart disease management. Sandy went into surgery early one morning and woke up in the afternoon. Endovascular stent grafts reinforce the area of the aorta . The Endurant family of products have been chosen by physicians to treat more than half a million patients worldwide. The TourGuide steerable sheath is available for sale in the United States and Europe.

Important Safety Information

100% three-year FF migration.

About the Valiant Thoracic Stent Graft

The Endurant II/Endurant IIs stent graft system is not recommended in patients unable to undergo or who will not be compliant with the necessary preoperative and postoperative imaging and implantation procedures as described in the Instructions for Use. We are committed to transforming healthcare by working with new partners, in new . The Valiant Navion thoracic stent graft system is expanding thoracic endovascular aortic repair (TEVAR) treatment, giving physicians access to solutions previously unavailable on a low-profile platform.

Heli-FX EndoAnchor

Latest clinical signals suggest aneurysm sac regression is associated with better long-term outcomes., Medtronic offers two stent graft systems for the treatment of AAA. For some patients, this reduces the recovery time by several days.Dissection Trial.Cardiothoracic procedures. As the stent graft is released, it expands to the proper size so that it fits into the aorta both above and below the aneurysm. As the first and only EVAR (endovascular aortic repair) system with a decade of global registry outcomes, Endurant systems continue to prove durability and strength in . Mean neck diameter 29. Morphology suitable for aneurysm repair.Sandy began his preparations, including a thorough cardiovascular exam. Minneapolis, MN 55432-5604 USA The Valiant ® Thoracic Stent Graft treats descending thoracic aortic aneurysms using a minimally invasive procedure called endovascular stent grafting. Additionally, the safety and .Endovascular Stent Grafts: (.Medtronic will work with patients, physicians, and hospitals to address any unreimbursed medical expenses incurred due to the Valiant Navion recall.Clinical Outcomes.Endurant II Stent Graft Systems. About a month after Sandy’s thoracic aortic aneurysm was diagnosed, it was repaired with a Medtronic Talent™ Thoracic Stent Graft. It is a flexible wire frame (stent) sewn onto a specially woven fabric tube (graft) that physicians may use to create a new path for blood flow in the patient’s aorta, reducing pressure on . Smooth dialator to sheath transition.5% three-year FF type Ia endoleak.Sentrant Introducer Sheath Features.EnChEVAR (Endurant II/IIs stent graft system + Radiant† balloon-expandable covered stent) analysis (n = 62)3. If you choose this treatment option, you’ll be joining more than 100,000 people with abdominal aortic aneurysm who’ve relied on Medtronic for relief over the past decade. Infrarenal neck angulation of ≤60 °. For the past 5 years, the Endurant II stent graft system has been used in 1 out of 2 EVAR . Distal fixation length of ≥15 mm. Why sac regression? Sac regression is defined by the SVS as the reduction in maximum diameter of the aneurysm sac by ≥ 5 mm.

Valiant Navion Safety Information

ValiantTM CaptiviaTM thoracic stent graft system. After endovascular stent graft repair of abdominal aortic aneurysm, patients can expect to return to most of their normal daily activities. Designed to provide unsurpassed conformability, control, and accuracy, the stent graft system offers a broad set of options to treat a wide range of patient anatomies. Enables in situ sizing with select ipsilateral limbs, allowing a 3-5 stent overlap for adjustment during case.pdf) (opens new window) A Treatment for Abdominal Aortic Aneurysms. Reinforced coiled tubing. Indications for Use: The Reliant™ Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels or to expand vascular prostheses.Important Information: Prior to use, refer to the Instructions for Use for indications, contraindications, suggested procedure, warnings and precautions.

Contact Medtronic for information about the aortic stent graft systems used to treat abdominal .

stent graft system) is to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.Indications for use. With endovascular stent graft therapy, it is not necessary to perform open-chest or open-abdominal aneurysm surgery.Precisely guide your next intervention with the TourGuide™ steerable sheath.Thoracic Endovascular Aortic Repair (TEVAR) TEVAR of the thoracic aorta is performed using an endovascular stent graft. iliac/femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories; nonaneurysmal aortic diameter in the range of 18 mm to 42mm (fusiform and saccular aneurysms/penetrating ulcers), 18 mm to 44 mm (blunt traumatic aortic injuries), or 20 . As the first and only EVAR (endovascular aortic repair) . The Valiant Thoracic Stent Graft is placed inside of the thoracic aortic aneurysm, without surgically .With more than 100,000 patients treated worldwide, the Valiant Captivia stent graft system is designed to treat all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), type B aortic dissection (TBAD), intramural hematoma (IMH), penetrating atherosclerotic ulcer (PAU), and blunt thoracic aortic injury (BTAI . The Medtronic Dissection Trial 2 was designed to evaluate the safety and effectiveness of the Valiant thoracic stent graft in the treatment of acute, complicated Type B dissection, as determined by all-cause mortality within 30 days of the index procedure, compared to a performance goal based on TEVAR and open surgical . The sheath can deflect up to 180° to facilitate the delivery of diagnostic and therapeutic devices to a wide variety of vessel takeoffs and challenging anatomical areas.The stent graft is slowly released from the delivery catheter into the aorta.For Abdominal Aortic Aneurysm. The thoracic stent graft is placed within the aneurysm to relieve pressure on the damaged vessel wall by enabling blood flow to bypass the aneurysm. I have read and agree with the Terms and Conditions *(opens new window). The stent graft system is comprised of 2 main components: the implan table stent graft and

Indications, Safety, and Warnings

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It is called minimally invasive, because with endovascular stent graft therapy it is not necessary to perform open-chest surgery or remove part of your aorta.The Endurant IIs stent graft: Provides up to a 20% reduction in distal diameter compared to select Endurant II bifurs. The Heli-FX™ EndoAnchor™ system is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. Renal complications may occur: 1) From an excess use of contrast agents.

Valiant Thoracic Stent Graft with Captivia Delivery System

Patients with lesions located in a saphenous vein graft, in the left main coronary artery, or ostial lesions; Patients with diffuse disease or poor flow distal to identified lesions; Patients with 3 vessel disease ; The safety and effectiveness of the stent have not been established in the cerebral, carotid, or peripheral vasculature.

Onyx Frontier DES

Working with Referral Physicians. t • s r d ) • y y • n -s • e d t • l s • s • y † Test data on file at Medtronic. Information on this site should not be used as a substitute for talking with your doctor.In this educational video series, leading specialists discuss their clinical experiences treating aortic dissection. Two working lengths: 28 cm and 64 cm. Product Details. Allows easier pre-case planning to simplify sizing. Outcome beyond 270 days for this permanent implant is unknown at present. The Endurant II Stent Graft System is contraindicated in: Patients who have a condition that .In February 2021, Medtronic issued a global voluntary recall of the Medtronic Valiant Navion™ Thoracic Stent Graft System. An abdominal aortic aneurysm is a bulging or ballooning in a part of your aorta that runs through your abdomen. The procedure is performed using long, thin tubes (catheters) to deliver the . His arteries were clear — there were no signs of atherosclerosis. With more than 100,000 patients treated . Treating Dissection. Optimize outcomes for . A rupture nearly always results in death. Costs that are directly related to patients’ medical care in connection with use of the Valiant Navion stent graft, including imaging, should be billed to the patients’ health insurance .ANCHOR Registry wide neck cohort three-year data (N = 72) 2. (Wide necks ≥ 28 mm and ≤ 32 mm.Select the Valiant™ thoracic stent graft with the Captivia™ delivery system for your thoracic endovascular aortic repair (TEVAR) procedures. The AAA stent is placed within the aneurysm to provide a permanent, alternative conduit for blood flow within the patient’s vasculature, thereby excluding the aneurysmal sac from blood flow and pressure and preventing the walls of the aneurysm .The Valiant thoracic stent graft with the Captivia delivery system is indicated for treatment of diseases of the descending thoracic aorta, including but not limited to, aneurysms and dissections. The Endurant II/IIs stent graft system is indicated for use in patients with the following characteristics: Adequate . The device is intended to assist in the expansion of . The Sentrant introducer sheath is the choice for superior hemostasis. Locking mechanism on dilator handle. It supports the weak area, so you can return to normal activities. Patients have reported feeling discomfort for the first few days following the endovascular stent grafting procedure. Endurant™ AAA stent graft systems.Medtronic Operational Headquarters 710 Medtronic Parkway .

Abdominal Aortic Aneurysm

Thoracic Endovascular Aneurysm Repair (TEVAR)

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