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EPI Statement

NEXUS® Aortic Arch Stent Graft System
Indications, Safety, and Warnings

CAUTION

Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATIONS

The NEXUS® Aortic Arch Stent Graft System is indicated for the endovascular treatment of chronic dissections involving the aortic arch in patients who are at high risk for open surgical repair and who have appropriate anatomy including:

  • Adequate iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories.

  • Proximal/ascending native landing zone aortic anatomy including:

  • 30 mm to 39 mm diameter;

  • ≥ 30 mm length

  • Landing zone cannot be aneurysmal, dissected, heavily thrombosed and tortuous

  • Proximal/ascending previously implanted surgical graft landing zone including:

  • 26 mm to 39 mm diameter;

  • ≥ 30 mm length

  • Brachiocephalic trunk native landing zone anatomy including:

  • 12.5 mm to 19.5 mm diameter;

  • ≥ 20 mm length

  • Landing zone cannot be aneurysmal, dissected, heavily thrombosed and tortuous

  • Distal/descending native landing zone aortic anatomy including:

  • 28 mm to 42 mm diameter;

  • ≥ 30 mm length

CONTRAINDICATIONS

The NEXUS® Aortic Arch Stent Graft System is contraindicated for use in:

  • Patient with known sensitivities or allergies to the device materials.

  • Patient who has a condition that threatens to infect the graft.

WARNINGS AND PRECAUTIONS

Read all the instructions carefully. Failure to properly follow the instructions, warnings, and precautions may lead to serious consequences and/or injuries to the patient, deterioration in patient’s health and even patient’s death (See Potential Adverse Events).

General

  • Patients without a formal diagnosis of connective tissue disease but who present with clinical features suggestive of such a condition (e.g., initial Type A dissection occurring at a young age) should not undergo implantation until the treating physician has confirmed that connective tissue disease is not present. The NEXUS® Aortic Arch Stent Graft System has not been evaluated in patients with connective tissue disease, and use in patients with known or suspected connective tissue disorders has resulted in serious adverse events, including death.

  • Failure to comply with the IFU of the NEXUS® Aortic Arch Stent Graft System has resulted in poor performance, severe complications and even death.

  • Compliance with device sizing recommendations is critical to optimal performance of the device (refer to Table 6 – Table 17). Successful patient selection requires specific imaging and accurate measurements (see Section 12.2 - Pre-Implant Determinants)

  • All patients should be advised this treatment modality requires long term, regular follow-up visits to assess the patients’ health status and device performance. Patients with specific clinical findings (e.g. endoleaks, enlarging lesions) should receive enhanced follow-up (see Section 9.2. Imaging Guidelines and Post-Operative Follow-up).

  • Safety and effectiveness of the NEXUS device has not been demonstrated for use in treatment of other lesion types such as aneurysms and penetrating aortic ulcers. Furthermore, the sizing recommendations outlined in this document are not applicable for use of the device in treatment of other pathologies.

  • The safety and effectiveness of the NEXUS® Aortic Arch Stent Graft System to treat chronic dissections involving the aortic arch, including in patients who are high risk for open repair, was determined based on a 30-day endpoint and 1 year follow-up.  Due to the short-term nature of this data, all patients should be advised that long-term, regular follow-up is necessary to assess the patients’ health status and device performance.

  • The safety and effectiveness of the NEXUS® Aortic Arch Stent Graft System have not been evaluated in patients who are not considered high risk candidates for conventional open repair (e.g. prior sternotomy, current or former smoker, and/or inadequate pulmonary function)

  • The NEXUS® Aortic Arch Stent Graft System should be used only by a physician with expertise in vascular interventional techniques and trained in the use of this system. Specific training expectations are described in Section 10.1, “Physician Training Requirements”.

  • The NEXUS® Aortic Arch Stent Graft System is not recommended in patients unable to undergo, or who will not be compliant with, the necessary pre- and post-operative imaging and follow-up described in Section 9.2. Imaging Guidelines and Post-Operative Follow-up.

  • Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aortas, endoleaks, dissection extension, or persistent false lumen perfusion. An increase in aortic size, persistent endoleak or continued false lumen perfusion may lead to aortic rupture, ischemia (such as peripheral malperfusion or ischemia or paraplegia/paraparesis), stroke, and/or death.

  • Unique considerations may apply for evaluation of endoleaks in the chronic dissection patients. Contrast opacification adjacent to the stent graft may represent false lumen perfusion or a Type II endoleak rather than a Type I or Type III endoleak. In the clinical study, misclassification of endoleak type has resulted in unnecessary or incorrect reinterventions. Careful imaging evaluation is recommended prior to reintervention.

  • Always have an appropriate surgical team readily available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary.

  • Prior to performing final angiography, ensure that all stiff guidewires have been fully withdrawn.  Failure to remove stiff wires before final imaging has resulted in inaccurate assessment of stent graft positioning, which has lead to improper device placement and serious adverse events, including death.

  • Patients experiencing reduced blood flow through the stent graft and/or leaks may be required to undergo secondary interventions or an open surgical procedure.

Patient Selection

  • Do not use the NEXUS® Aortic Arch Stent Graft System in patients who do not tolerate contrast agents necessary for preoperative, intra-operative and post-operative follow-up imaging. Not following this instruction may lead to serious injuries to the patient, deterioration in patient’s health and even patient’s death.

  • The use of this device requires administration of radiographic agents. Patients with preexisting renal insufficiency  have an increased risk of renal failure postoperatively.

  • The NEXUS® Aortic Arch Stent Graft System is not recommended in patients exceeding weight and/or size limits which compromise or prevent the necessary imaging requirements. Before the procedure, perform preoperative planning for access and placement. Refer to Section 2.2 (Recommended device sizing). Key anatomic elements that may affect successful exclusion of the aneurysm include tortuosity, short landing zones, and significant thrombus and/or calcium at the implantation sites. In the presence of anatomical limitations, a longer landing zone may be required to obtain adequate sealing and fixation.

  • Key anatomic elements may affect successful exclusion of the thoracic lesion and are provided in the Indications For Use Section 3 and in the Recommended Device Sizing Section 2.3. (see Figure 6a)

  • The Nexus device is not recommended in patients where the angle between the center line of Brachiocephalic Artery and a line perpendicular to the Aortic Arch center line is less than 125° (see Figure 6b) as this may result in the need for additional endovascular intervention (e.g., stenting of the BCT).

  • The Nexus device is not recommended in patients where the aorta at the level of the BCT has a diameter (perpendicular to the aortic centerline) of less than 30 mm as this may result in endoleak requiring further intervention, either endovascular or open. This is important to allow the Arch Docking Sleeve to fully expand (see Figure 6b).

  • Patients who have a previously implanted surgical wrap of the ascending aorta should not be treated with the NEXUS® Aortic Arch Stent Graft System.

  • Severe calcification in the access vessels may impede device delivery, and therefore, it should be evaluated while making decisions regarding access suitability.

  • Blood vessels that are significantly calcified, stenosed, tortuous or thrombus-lined should be precluded from endovascular treatment.

  • Additional key anatomic elements include presence of significant thrombus and/or calcium deposits at the implantation sites, specifically at the proximal aortic neck. Presence of calcification and/or plaque may compromise the fixation and sealing of the implantation site. It may also promote emboli formation and lead to occurrence of adverse events such as ischemia downstream. Surgical revascularization of the required supra-aortic vessels (e.g., right carotid–left carotid–left subclavian bypass) must be completed prior to implantation of the NEXUS® Aortic Arch Stent Graft System. Proximal ligation or endovascular occlusion of the left subclavian artery and ligation of the left common carotid artery should be performed to mitigate the risk of competitive flow that may compromise bypass patency and to reduce the risk of Type II endoleaks.

  • The safety and effectiveness of NEXUS® have not been evaluated in the following patient conditions:

  • Acute dissections or conditions requiring emergent treatment (e.g., trauma or rupture)

  • Acute vascular injury of the aorta due to trauma

  • Aortic fistulas

  • Previous surgical repair in the descending thoracic aortic area

  • Genetic connective tissue disease (e.g. Marfans and Ehlers-Danlos syndrome)

  • Patients with active systemic infections

  • Patients less than 18 years old

  • Pregnant or nursing females

  • Patients with mechanical aortic valves

  • Patients that are not considered high risk candidates for conventional open surgical repair

  • Severe aortic valvular insufficiency

  • Severe atherosclerosis, severe calcification or extensive intraluminal thrombus of the aorta or in the brachiocephalic trunk

  • Patients that are high risk of a neurological event (e.g. stroke)

  • Do not use NEXUS® in patients who have a condition that threatens to infect the graft.

  • Inappropriate patient selection may lead to poor device performance or performance not in accordance with the specifications. This could result in injury to the patient, deterioration in patient’s health and even patient’s death.

  • In the presence of anatomical limitations, a longer landing zone and additional stent grafts may be required to obtain adequate sealing and fixation.

  • In case the difference between the proximal and distal intended landing diameters does not enable sufficient oversizing offered by a single DE endoprosthesis, a combination of multiple DE stent grafts of different diameters is required.

Before Implantation

  • A right carotid-left carotid- left subclavian bypass is recommended for surgical revascularization of the supra-aortic vessels. In the clinical study, higher rates of mortality were reported for patients who underwent mini-sternotomy as compared to the extra thoracic bypass procedure.

  • Patients undergoing prior surgical bypass preparatory procedures may require variable recovery periods. The timing of subsequent NEXUS implantation should be determined by clinical judgment following a thorough assessment of the patient's recovery status. The implant procedure should be deferred until the patient is deemed sufficiently recovered from the bypass (e.g. could be discharged home).  Insufficient recovery at the time of implantation has resulted in increased risk of adverse events, including death.

  • BCA length should be carefully re-measured after completion of the preparatory bypass and prior to implantation of the NEXUS® Aortic Arch Stent Graft System to reconfirm the NEXUS® Arch Stent Graft branch length is appropriate for the patient’s BCA anatomy. This step is particularly important if a mini-sternotomy was performed instead of the recommended right carotid-left carotid-left subclavian bypass.  Failure to reconfirm BCA length has resulted in inadvertent coverage of the carotid artery or bypass origin and has led to serious adverse events, including death.

  • Pre-operative planning for vascular access, for through & through access and for device placement should be performed before the operation.

  • To reduce the risk of thromboembolism, it is recommended that patients be anticoagulated for the duration of the procedure to achieve an Activated Clotting Time of > 350 seconds, at the discretion of the physician.

  • Prior to use, carefully inspect the NEXUS® Aortic Arch Stent Graft System packaging and the delivery system for damage or defects, including broken flushing luer lock, or detachments of the delivery system from the tray. Do not use product if any sign of damage or breach of the sterile barrier is observed. Do not attempt to re-sterilize the NEXUS® Aortic Arch Stent Graft System or its components.

  • Do not bend, kink, or otherwise challenge the Delivery System prior to implantation because it may cause deployment difficulties.

  • Size the aortic portion of the stent graft using the sizing guidelines in Section 2.3 (Recommended device sizing). Strictly adhere to the NEXUS® thoracic stent graft system sizing configurations and guidelines (section 2.2) when selecting the device size. The appropriate device oversizing is incorporated into the sizing guidelines. Sizing outside of this range can potentially result in endoleak, fracture, migration, in-folding, or graft wear.

During Implantation

  • Systemic anticoagulation should be used during the implantation procedure based on hospital or physician protocol.

  • If heparin is contraindicated, an alternative anticoagulant should be considered.

  • Exercise care in handling and in delivery technique to prevent blood vessel rupture.

  • Do not advance the delivery system without having placed a guide wire first and without fluoroscopy. This may lead to major vascular complication, and even to patient’s death.

  • A suitable introducer sheath must be used for the Through & Through guide wire technique to accommodate the guide wire. In addition, the guide wire should remain in place and stressed until the Arch Stent Graft is deployed in-situ in order to avoid migration of the main stent graft during procedure. Migration can lead to inadequate sealing of the lesion and even to innominate artery occlusion which could result in stroke and even death.

  • Do not deploy the stent graft components in a location that can cause an endoleak or can occlude arteries necessary to supply blood flow to vital organs. This has resulted in need for surgical removal of the device.

  • Use fluoroscopic guidance to advance the delivery system in order to detect kinking or positioning problems with the stent graft components. Deviating from the image guided target location marking has resulted in the BCT branch being deployed too distally which has led to vascular injuries to the patient, deterioration in patient’s health and even patient’s death.

  • Do not use excessive force to advance or withdraw the delivery system when resistance is encountered, it may lead to improper performance and may result in vascular injury to the patient and even patient’s death. If resistance is felt during advancement or withdrawal of the guidewire or delivery system, stop and assess the cause of resistance. If the delivery system kinks during insertion, do not attempt to deploy the stent graft component. Remove the system and insert a new delivery system.

  • Improper alignment of the radiopaque dot markers of the Ascending Curved Stent Graft with the radiopaque large ring of the Arch-Stent Graft and/or improper direction of “B” marker of the Ascending Curved Stent Graft (must be turned toward the cranial side of the aorta) may impair the connection of the two stent grafts and may result in endoleak or occlusion of the innominate artery which can result in stroke and even death.

  • Improper alignment of the radiopaque “B” marker of the DE Stent Graft with the radiopaque dot marker of its overlapping stent graft may impair the connection of the two stent grafts and may result in endoleak.

  • While in situ and for the purpose of correct orientation of the markers, do not rotate the Arch Stent Graft and the Ascending Curved Stent Graft delivery systems grip more than 360 degrees. In case the delivery system does not rotate, gently pull the delivery system backward out of the aortic arch and correct the marker orientation by rotating the delivery system grip (not more than 360 degrees), and advance the delivery system to the correct position. While in place, verify correct orientation before deployment.

  • Inadequate seal zone could increase the risk of endoleak or migration of the stent graft. Migration may also be caused by deployment of the proximal stent into a thrombus filled or severely angled vessel. Refer to section 5.2 (Patient selection).

  • When deploying the stent graft, be sure to hold the front Grip of the delivery system stationary in order to ensure adequate implantation and avoid inaccurate positioning of the stent grafts and as a result endoleak or occlusion of the innominate artery which can result in stroke and even death.

  • Rapid Heart Pacing or other available techniques to reduce cardiac output and blood pressure, is recommended to be used during the deployment of the Ascending Curved Stent Graft.

  • Ensure that the Arch Stent Graft and the DE Stent Graft are deployed against the outer curve of the vasculature, e.g. by applying forward pressure on either the delivery system or both ends of its corresponding guidewire. As default, it is possible to deploy the overlapping segment of the DE stent graft for primary fixation then carefully apply minor pressure on the DS to accommodate the outer curve before completing the deployment. Note: avoid excess force that might result in relative stent graft migration or other hazardous disposition of adjacent implants.

  • Stent graft components cannot be replaced or drawn back into the delivery system, even if the stent graft component is only partially deployed.

  • If a balloon catheter is used, it should be inflated only inside the stent graft. Do not inflate outside the stent graft nor in the border area of the stent graft with the aortic wall. Do not over inflate the balloon catheter within or outside of the graft material. Follow the balloon catheter manufacturer Instructions for Use.

  • Manipulation of wires, balloons, catheters, and endografts in the thoracic aorta has resulted in vascular trauma including aortic dissection, embolization, and cardiac perforation.

  • Renal complications may occur from excess use of contrast agents, or as a result of embolization.

  • Studies indicate that the danger of micro-embolization or stroke increases with increased catheter and guidewire manipulation1,2..

  • Ensure that extra extensions and stents of suitable diameters are available in the operating room.

POTENTIAL ADVERSE EVENTS

As for all medical devices and procedures, complications may occur with the implantation of the NEXUS® Aortic Arch Stent Graft System. The following adverse events may occur for conventional similar procedures with endovascular stent- graft devices, as well as with the NEXUS®. As the patient may undergo additional medical treatments for other underlying disease conditions, each of these medical conditions may cause a multitude of complications and adverse events. The potential adverse events, which may occur with the use of the NEXUS® include, but are not limited to:

  • Abscess formation

  • Acute respiratory distress syndrome (ARDS)

  • Adverse foreign body response

  • Allergies (including

  • Amputation

  • Anesthetic complications and subsequent attendant problems

  • Aneurysm enlargement or rupture

  • Angina

  • Aortic damage

  • Aortic enlargement

  • Aortic regurgitation

  • Aortic valve damage and/or functional impairment

  • Arrhythmia

  • Arteriovenous fistula

  • Aortoesophageal fistula

  • Bleeding/bleeding com

  • Cardiac complications and subsequent attendant problems

  • Claudication (e.g. buttock, lower limb)

  • Congestive heart failure

  • Contrast Toxicity

  • Coronary arteries occlusion

  • Coronary arteries stenosis

  • Death

  • Dissection Extension

  • Dissection of a vessel

  • Edema

  • Embolization (micro and macro)

  • Emergency operation including surgical conversion to open repair

  • Endoleak

  • Erosion

  • Fistula

  • Fever

  • Genitourinary complications and subsequent attendant problems including erosion

  • Hematoma

  • Hematuria

  • Hemorrhage, requiring blood transfusion

  • Hemorrhagic pleural effusion

  • Heparin-induced thrombocytopenia (HIT)

  • Hepatic Failure

  • Hypertension

  • Hypotension

  • Ileus

  • Impotence

  • Incontinence

  • Infarction

  • Infection

  • Inflammation (localized or general)

  • Ischemia transient or permanent

  • Ischemic effects to the limbs, genitourinary system including kidneys, myocardium, mesentery, brain and spinal cord

  • Lymphatic complications and subsequent attendant problems (lymphocele)

  • Multiple organ failure syndrome (MOF)

  • Myocardial infarction

  • Myocardial perforation

  • Necrosis

  • Neurologic complications including lipothymy and encephalopathy

  • Obstruction/occlusion

  • Pain

  • Paralysis including vocal cords and diaphragm

  • Paralysis of vocal cords

  • Paraparesis

  • Paraplegia

  • Pericardial tamponade

  • Perforation of a vessel wall

  • Peritonitis

  • Persistent False Lumen

  • Pseudoaneurysm

  • Pulmonary complications and subsequent attendant problems

  • Radiation exposure risks / repetitive radiation sessions

  • Renal Insufficiency/failure

  • Rupture of a vessel

  • Sepsis

  • Seroma

  • Stenosis

  • Stent graft complications: improper component placement; incomplete component deployment; inadequate apposition, “beaking” and subsequent collapse of the component; clinically significant component migration; suture break; stent fracture; graft twisting or kinking; insertion and removal difficulties; graft material wear; dilatation; erosion; puncture and perigraft flow

  • Stroke

  • Syncope

  • Temporary Neurological Deficit (TND)

  • Thrombosis

  • Transient ischemic attack (TIA)

  • Vascular access site complications including lymphocele

  • Vascular spasm or vascular trauma

  • Ventricular fibrillation

  • Ventricular tachycardia

  • Vessel damage

  • Wound complications including dehiscence and cellulitis

Device Related Adverse Event Reporting

Any adverse event involving the NEXUS® Aortic Arch Stent Graft System should be reported to the manufacturer and the country specific regulatory authorities immediately. To report an event to Endospan, email: info@endospan.com or contact: US: Phone: 1-800-374-0570 or Israel: +972-9-7884620

The NEXUS Multi-Branch Aortic Arch Stent Graft System is a custom-made device.
Custom-made devices are not available in the US and availability is subject to local regulatory approval.

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