1. Witzenbichler B et al. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents: The ADAPT-DES Study. Circulation 2014 Jan: 129,4;463-470.
3. Co-registration tools available within IntraSight 7 configuration via SyncVision.
4. Millenium Research Group, US Marketrack internal sales data on file
5. Results obtained during usability study performed in December 2016. The study involved 33 participants. Participants were spread evenly over technologist/nurses and physicians. To evaluate benefits of the multi-user capabilities of the new system design and user satisfaction, its novel design was tested by participants that had relevant working experience in the interventional lab and who had not previously used the new system.
6. Results obtained during user tests performed in 2017/2018 by Philips Healthcare and Use-Lab GmbH, an independent company. The tests involved 17 physicians from Europe and the USA, who performed simulated procedures in a simulated OR environment.
7. Results are specifific to the institution where they were obtained and may not reflflect the results achievable at other institutions. Results obtained by the Interventional Vascular Department at St. Antonius Hospital.
8. Patel M. “Cost-effectiveness of instantaneous wave-Free Ratio (iFR) compared with Fractional Flow Reserve (FFR) to guide coronary revascularization decision making.” Late-breaking Clinical Trial presentation at ACC on March 10, 2018.
9. Davies JE, et al., Use of the Instantaneous Wave-free Ration or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834.
10. Davies JE, et al., DEFINE-FLAIR: A Multi- Centre, Prospective, International, Randomized, Blinded Comparison of Clinical Outcomes and Cost Effifficiencies of iFR and FFR Decision-Making for Physiological Guided Coronary Revascularization. New England Journal of Medicine, epub March 18, 2017.
11. Gotberg M, et al., Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve Guided Intervention (IFR-SWEDEHEART): A Multicenter, Prospective, Registry-Based Randomized Clinical Trial. New England Journal of Medicine, epub March 18, 2017.
12 Patel M. “Cost-effectiveness of instantaneous wave-Free Ratio (iFR) compared with Fractional Flow Reserve (FFR) to guide coronary revascularization decision-making.” Late-breaking Clinical Trial presentation at ACC on March 10, 2018.
13. Virmani R, Farb A, Burke AP. Coronary angioplasty from the perspective of atherosclerotic plaque: Morphologic predictors of immediate success and restenosis. Am Heart J. 1994;127:163–79.
14. The Excimer laser coronary atherectomy catheters (ELCA) are used in conjunction with the Spectranetics CVX-300 Excimer laser system and are intended for use in patients with a variety of blockages in single or multivessel coronary artery disease. ELCA is usually used in conjunction with other therapies, such as balloon angioplasty or stenting. The use of ELCA may be unsafe in some patients or in treating certain types of blockages. The ELCA X-80 catheter should not be used in patients with weakened heart muscles (ejection fraction <30%) or in cases of acute heart attacks. Rarely a patient undergoing ELCA may require urgent surgical treatment for a complication; therefore, patients who are not candidates for coronary bypass graft surgery should not undergo treatment with ELCA. Ask your doctor if you are a candidate for ELCA. Potential adverse events ssociated with procedures used to treat coronary artery disease may include: a tear, rupture, damage to the artery; a sudden, temporary or ongoing re-closure of the treated artery; blood clot or obstruction of the artery by plaque debris. Other complications may occur. Rare but serious potential adverse events include: the need for urgent additional procedures or surgery due to bleeding, vascular damage, loss of blood flow or other complications; and irregular heartbeat, heart attack or death. This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you. The AngioSculpt scoring balloon catheter is indicated for use in the treatment of hemodynamically signifificant coronary artery stenosis, including in-stent restenosis, for the purpose of improving myocardial perfusion.
15. The AngioSculpt catheter should not be used for coronary artery lesions unsuitable for treatment by percutaneous revascularization, and coronary artery spasm in the absence of a significant stenosis. Possible adverse effects include, but are not limited to: death; heart Attack (acute myocardial infarction); total occlusion of the treated artery; coronary artery dissection, perforation, rupture, or injury; pericardial tamponade; no/slow reflflow of treated vessel; emergency coronary artery bypass (CABG); emergency percutaneous coronary intervention; CVA/ stroke; pseudoaneurysm; restenosis of the dilated vessel; unstable chest pain (angina); thromboembolism or retained device components; irregular heart rhythm (arrhythmias, including life-threatening ventricular fibrillation); severe low (hypotension)/high (hypertension) blood pressure; coronary artery spasm; hemorrhage or hematoma; need for blood transfusion; surgical repair or vascular access site; creation of a pathway for blood flflow between the artery and the vein in the groin (arteriovenous fifistula); drug reactions, allergic reactions to x-ray dye (contrast medium); and infection. This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.
16. Routine coronary interventions comprise of fluoroscopy and exposure usage.
17. 95% CI of 53%, 77% for all diagnostic and interventional coronary procedures. The results of the application of dose reduction techniques will vary depending on the clinical task, patient size, anatomical location and clinical practice. The interventional cardiologist assisted by a physicist as necessary has to determine the appropriate settings for each specific clinical task.
18. Results based on total dose area product from a single center prospective controlled randomized study (University Hospital Ghent, Belgium) on 122 patients (42 for Allura Xper and 80 for AlluraClarity) undergoing coronary procedures. Of the 122 patients, 102 (83.6%) had a diagnostic procedure without intervention and 51 (41.8%) resulted in a diagnosis of no coronary disease. Patient radiation exposure was quantified using cumulative dose area product as collected from Radiation Dose Structured Reports and/or Allura Reports. Baseline dose was maintained by confifiguring both systems to power up with the lowest dose settings as default and default procedure settings for cardio were used. Exam duration and fluoro time was consistent between the systems and an increase in number of exposure images and runs with the AlluraClarity was attributed to the biplane configuration compared to the monoplane configuration of the Allura Xper.
ELCA
The Excimer laser coronary atherectomy catheters (ELCA) are used in conjunction with the Spectranetics CVX-300 Excimer laser system and are intended for use in patients with a variety of blockages in single or multivessel coronary artery disease. ELCA is usually used in conjunction with other therapies, such as balloon angioplasty or stenting. The use of ELCA may be unsafe in some patients or in treating certain types of blockages. The ELCA X-80 catheter should not be used in patients with weakened heart muscles (ejection fraction <30%) or in cases of acute heart attacks. Rarely a patient undergoing ELCA may require urgent surgical treatment for a complication; therefore, patients who are not candidates for coronary bypass graft surgery should not undergo treatment with ELCA. Ask your doctor if you are a candidate for ELCA. Potential adverse events associated with procedures used to treat coronary artery disease may include: a tear, rupture, damage to the artery; a sudden, temporary or ongoing re-closure of the treated artery; blood clot or obstruction of the artery by plaque debris. Other complications may occur. Rare but serious potential adverse events include: the need for urgent additional procedures or surgery due to bleeding, vascular damage, loss of blood flflow or other complications; and irregular heartbeat, heart attack or death. This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.
AngioSculpt PTCA
The AngioSculpt scoring balloon catheter is indicated for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis, for the purpose of improving myocardial perfusion. The AngioSculpt catheter should not be used for coronary artery lesions unsuitable for treatment by percutaneous revascularization, and coronary artery spasm in the absence of a signifificant stenosis. Possible adverse effffects include, but are not limited to: death; heart Attack (acute myocardial infarction); total occlusion of the treated artery; coronary artery dissection, perforation, rupture, or injury; pericardial tamponade; no/slow reflow of treated vessel; emergency coronary artery bypass (CABG); emergency percutaneous coronary intervention; CVA/ stroke; pseudoaneurysm; restenosis of the dilated vessel; unstable chest pain (angina); thromboembolism or retained device components; irregular heart rhythm (arrhythmias, including life-threatening ventricular fifibrillation); severe low (hypotension)/high (hypertension) blood pressure; coronary artery spasm; hemorrhage or hematoma; need for blood transfusion; surgical repair or vascular access site; creation of a pathway for blood flow between the artery and the vein in the groin (arteriovenous fistula); drug reactions, allergic reactions to x-ray dye (contrast medium); and infection.
This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.
Prescription Use Statement
Caution: Federal law restricts this device to sale by or on the order of a physician
