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FREMONT, Calif.--(BUSINESS WIRE)--Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today announced conformité européenne (CE) Mark for the company’s Coronary Lithoplasty® System for the treatment of calcified plaque in conjunction with stenting in patients with coronary artery disease. The Shockwave Medical Coronary Lithoplasty System is an innovative therapy designed to treat calcified coronary artery blockages with lithotripsy, sonic pressure waves historically used to treat patients with kidney stones. The presence of calcified coronary artery disease leads to suboptimal outcomes for all treatment options – medical therapy, interventional treatment and cardiac surgery.1 For angioplasty with a stent, the presence of calcified lesions is associated with suboptimal lesion expansion, poor stent apposition and complications including dissection, distal embolization, coronary hypoperfusion and procedural failure.2 Specialty balloons and atherectomy are current adjunctive therapies designed to modify coronary calcium. Their use is limited due to risk of complications, degree of technical difficulty, operator dependency or lack of sufficient evidence.1,3 “Cardiovascular calcification presents a persistent treatment challenge for the interventionalist,” said Jean Fajadet, M.D., co-director of the Interventional Cardiovascular Group at Clinique Pasteur in Toulouse, France, and co-principal investigator of the DISRUPT CAD I clinical trial of the technology. “The use of Lithoplasty in the coronary arteries is an important new option that has shown, in the DISRUPT CAD I clinical study of the device, to effectively prepare the vessel for stent implantation with minimal complications. I look forward to commercial availability of the system.” Safety and performance was supported by clinical data from results of DISRUPT CAD I, a pre-market, prospective multi-center single-arm study conducted at seven centers in Europe and Australia. The study evaluated the use of the Shockwave Medical Coronary Lithoplasty System as a treatment for calcified coronary arteries prior to drug eluting stent (DES) implantation. Primary endpoint results from the study were reported last fall at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C. “CE Mark for the Coronary Lithoplasty System is an important milestone for Shockwave Medical,” said Shockwave Medical CEO Doug Godshall. “With this achievement, we are a step closer to bringing Lithoplasty to patients and physicians in Europe as a potentially paradigm-changing technology for the treatment of coronary artery disease. We look forward to sharing our final six-month results from DISRUPT CAD I at EuroPCR this week, and to continuing to gather clinical evidence on the benefits of this promising treatment for a challenging patient population.” In addition, Shockwave Medical announced the following schedule of presentations at the annual EuroPCR 2017 conference taking place May 16-19 at the Palais des Congrès in Paris: Shockwave Medical’s Lithoplasty System integrates angioplasty balloon catheter devices with the calcium-disrupting power of sonic pressure waves, known as lithotripsy. Each Lithoplasty catheter incorporates multiple lithotripsy emitters activated with the touch of a button after the balloon is inflated. Once activated, these emitters produce therapeutic sonic pressure waves that are inherently tissue-selective, passing through the balloon and soft vascular tissue, preferentially disrupting the calcified plaque inside the vessel wall and creating a series of micro-fractures. When the calcium has been modified, the vessel can be dilated using low pressures, thereby enabling even historically challenging patients to be treated effectively with minimal injury to the vessel. To view an animation of the Lithoplasty System visit http://shockwavemedical.com. In the European Union, the Shockwave Medical Coronary Rx Lithoplasty System is indicated for lithotripsy enhanced, low-pressure balloon dilatation of calcified, stenotic de novo coronary arteries prior to stenting. The Shockwave Medical Coronary Lithoplasty System and the Shockwave Medical Transcatheter Aortic Valve Lithotripsy System are investigational devices in the United States and are not available for sale. Shockwave Medical, based in Fremont, Calif., is working to reshape interventional therapy with Lithoplasty® Technology for the treatment of calcified peripheral vascular, coronary vascular and heart valve disease. For more information, visit www.shockwavemedical.com. 1 Madhavan M, Généreux P, et al. Coronary Artery Calcification: Pathogenesis and Prognostic Implications. J Am Coll Cardiol 2014;63:1703–14. 2 Lee M, Shah N. The Impact and Pathophysiologic Consequences of Coronary Artery Calcium Deposition in Percutaneous Coronary Interventions. J Invasive Cardiol 2016;28(4):160-167. 3 Tomey M, Kini A, Sharma S. Current Status of Rotational Atherectomy. J Am Coll Cardiol Intv 2014;7:345–53.


The Edwards CENTERA valve is repositionable and retrievable and can be delivered through a low-profile 14-French delivery system that features a motorized handle that results in stable valve deployment. The valve is uniquely packaged – fully pre-attached which facilitates simple and rapid device preparation. "The Edwards CENTERA valve demonstrates extremely favorable early clinical safety and performance outcomes in the high surgical risk TAVR population," said Didier Tchétché, M.D., of Clinique Pasteur in Toulouse, France, who presented the data. "In addition to excellent patient outcomes, the valve also offers several unique features and an innovative tissue design, all of which simplify the procedure for clinicians." CENTERA-EU Trial patients were enrolled in 23 centers in Europe, Australia and New Zealand and will be followed for five years. The Edwards CENTERA valve is an investigational device not yet available commercially in any country. Edwards anticipates it will receive CE Mark approval for the CENTERA valve during the fourth quarter. Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.Edwards.com and follow us on Twitter @EdwardsLifesci. This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, Dr. Tchétché's statements and statements regarding expected future product benefits and results. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unexpected outcomes after longer term clinical experience with the product; or unanticipated quality, manufacturing or regulatory delays or issues. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2016. These filings, along with important safety information about our products, may be found at edwards.com. Edwards, Edwards Lifesciences, the stylized E logo, and CENTERA are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/edwards-novel-self-expanding-transcatheter-heart-valve-demonstrates-excellent-early-patient-outcomes-300459074.html


Noc M.,University of Ljubljana | Fajadet J.,Clinique Pasteur | Lassen J.F.,Aarhus University Hospital | Kala P.,Masaryk University | And 4 more authors.
EuroIntervention | Year: 2014

Due to significant improvement in the pre-hospital treatment of patients with out-of-hospital cardiac arrest (OHCA), an increasing number of initially resuscitated patients are being admitted to hospitals. Because of the limited data available and lack of clear guideline recommendations, experts from the EAPCI and 'Stent for Life' (SFL) groups reviewed existing literature and provided practical guidelines on selection of patients for immediate coronary angiography (CAG), PCI strategy, concomitant antiplatelet/anticoagulation treatment, haemodynamic support and use of therapeutic hypothermia. Conscious survivors of OHCA with suspected acute coronary syndrome (ACS) should be treated according to recommendations for ST-segment elevation myocardial infarction (STEMI) and high-risk non-ST-segment elevation -ACS (NSTE-ACS) without OHCA and should undergo immediate (if STEMI) or rapid (less than two hours if NSTE-ACS) coronary invasive strategy. Comatose survivors of OHCA with ECG criteria for STEMI on the post-resuscitation ECG should be admitted directly to the catheterisation laboratory. For patients without STEMI ECG criteria, a short 'emergency department or intensive care unit stop' is advised to exclude non-coronary causes. In the absence of an obvious non-coronary cause, CAG should be performed as soon as possible (less than two hours), in particular in haemodynamically unstable patients. Immediate PCI should be mainly directed towards the culprit lesion if identified. Interventional cardiologists should become an essential part of the 'survival chain' for patients with OHCA. There is a need to centralise the care of patients with OHCA to experienced centres. © Europa Digital & Publishing 2014.


Portalez D.,Clinique Pasteur | Mozer P.,Hopital Pitie Salpetriere | Cornud F.,Hopital Cochin | Renard-Penna R.,Hopital Pitie Salpetriere | And 3 more authors.
European Urology | Year: 2012

Background: Wide variations in acquisition protocols and the lack of robust diagnostic criteria make magnetic resonance imaging (MRI) detection of prostate cancer (PCa) one of the most challenging fields in radiology and urology. Objective: To validate the recently proposed European Society of Urogenital Radiology (ESUR) scoring system for multiparametric MRI (mpMRI) of the prostate. Design, setting, and participants: An institutional review board-approved multicentric prospective study; 129 consecutive patients (1514 cores) referred for mpMRI after at least one set of negative biopsies. Intervention: Transfer of mpMRI-suspicious areas on three-dimensional (3D) transrectal ultrasound images by 3D elastic surface registration; random systematic and targeted cores followed by core-by-core analysis of pathology and mpMRI characteristics of the core locations. The ESUR scores were assigned after the procedure on annotated Digital Imaging and Communications in Medicine archives. Outcome measurements and statistical analysis: Relationships between ESUR scores and biopsy results were assessed by the Mann-Whitney U test. The Yates correction and Pearson χ2 tests evaluated the association between categorical variables. A teaching set was randomly drawn to construct the receiver operating characteristic curve of the ESUR score sum (ESUR-S). The threshold to recommend biopsy was obtained from the Youden J statistics and tested in the remaining validation set in terms of sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. Results and limitations: Higher T2-weighted, dynamic weighted imaging and dynamic contrast-enhanced ESUR scores were observed in areas yielding cancer-positive cores. The proportion of positive cores increased with the ESUR-S aggregated in five increments (ESUR-S 3-5: 2.9%; ESUR-S 6-8: 11.1%; ESUR-S 9-10: 38.2%; ESUR-S 11-12: 63.4%; and ESUR-S 13-15: 83.3%; p < 0.0001). A threshold of ESUR-S ≥9 exhibited the following characteristics: sensitivity: 73.5%; specificity: 81.5%; positive predictive value: 38.2%; negative predictive value: 95.2%; and accuracy: 80.4%. Although the study was not designed to compare repeat biopsy strategies, more targeted cores than random systematic cores were found to be positive for cancer (36.3% compared with 4.9%, p < 0.00001). Conclusions: In the challenging situation of repeat biopsies, the ESUR scoring system was shown to provide clinically relevant stratification of the risk of showing PCa in a given location.© 2012 European Association of Urology.


Chieffo A.,San Raffaele Scientific Institute | Buchanan G.L.,San Raffaele Scientific Institute | Van Mieghem N.M.,Erasmus Medical Center | Tchetche D.,Clinique Pasteur | And 11 more authors.
Journal of the American College of Cardiology | Year: 2013

Objectives: The aim of this study was to compare outcomes after transfemoral transcatheter aortic valve implantation with the Medtronic CoreValve (MCV) versus the Edwards SAPIEN/SAPIEN XT transcatheter heart valve (ESV) for severe aortic stenosis. Background: No large matched comparison study has been conducted so far evaluating both commercially available devices. Methods: The data from databases of 4 experienced European centers were pooled and analyzed. Due to differences in baseline clinical characteristics, propensity score matching was performed. Study objectives were Valve Academic Research Consortium outcomes at 30 days and 1 year. Results: In total, 793 patients were included: 453 (57.1%) treated with the MCV and 340 (42.9%) with the ESV. After propensity matching, 204 patients were identified in each group. At 30 days, there were no differences in all-cause mortality (MCV, 8.8% vs. ESV, 6.4%; hazard ratio [HR]: 1.422; 95% confidence interval [CI]: 0.677 to 2.984; p = 0.352), cardiovascular mortality (MCV, 6.9% vs. ESV, 6.4%; HR: 1.083; 95% CI: 0.496 to 2.364; p = 0.842), myocardial infarction (MCV, 0.5% vs. ESV, 1.5%; HR: 0.330; 95% CI: 0.034 to 3.200; p = 0.339), stroke (MCV, 2.9% vs. ESV, 1.0%; HR: 3.061; 95% CI: 0.610 to 15.346; p = 0.174), or device success (MCV, 95.6% vs. ESV, 96.6%; HR: 0.770; 95% CI: 0.281 to 2.108; p = 0.611). Additionally, there were no differences in major vascular complications (MCV, 9.3% vs. ESV, 12.3%; HR: 0.735; 95% CI: 0.391 to 1.382; p = 0.340) or life-threatening bleeding (MCV, 13.7% vs. ESV, 8.8%; HR: 1.644; 95% CI: 0.878 to 3.077; p = 0.120). MCV was associated with more permanent pacemakers (22.5% vs. 5.9%; HR: 4.634; 95% CI: 2.373 to 9.050; p < 0.001). At 1 year, there were no differences in all-cause (MCV, 16.2% vs. ESV, 12.3%; HR: 1.374; 95% CI: 0.785 to 2.407; p = 0.266) or cardiovascular (MCV, 8.3% vs. ESV, 7.4%; HR: 1.145; 95% CI: 0.556 to 12.361; p = 0.713) mortality. Conclusions: No differences between the 2 commercially available transfemoral transcatheter aortic valve implantation devices were observed at the adjusted analysis in Valve Academic Research Consortium outcomes except for the need for permanent pacemakers with the MCV. © 2013 American College of Cardiology Foundation.


Gregorini L.,University of Milan | Marco J.,Clinique Pasteur | Heusch G.,University of Duisburg - Essen
Journal of Molecular and Cellular Cardiology | Year: 2012

A percutaneous coronary intervention (PCI) is a unique condition to study the effects of ischemia and reperfusion in patients with severe coronary atherosclerosis when coronary vasomotor function is compromised by loss of endothelial and autoregulatory vasodilation. We studied the effects of intracoronary non-selective α-, as well as selective α 1- and α 2-blockade in counteracting the observed vasoconstriction in patients with stable and unstable angina and in patients with acute myocardial infarction. Coronary vasoconstriction in our studies was a diffuse phenomenon and involved not only the culprit lesion but also vessels with angiographically not visible plaques. Post-PCI vasoconstriction was reflected by increased coronary vascular resistance and associated with decreased LV-function. α 1-Blockade with urapidil dilated epicardial coronary arteries, improved coronary flow reserve and counteracted LV dysfunction. Non-selective α-blockade with phentolamine induced epicardial and microvascular dilation, while selective α 2-blockade with yohimbine had only minor vasodilator and functional effects. Intracoronary α-blockade also attenuated the no-reflow phenomenon following primary PCI. This article is part of a Special Issue entitled "Coronary Blood Flow". © 2011 Elsevier Ltd.


Stone G.W.,Columbia University Medical Center | Teirstein P.S.,Scripps Research Institute | Meredith I.T.,Monash Medical Center | Farah B.,Clinique Pasteur | And 6 more authors.
Journal of the American College of Cardiology | Year: 2011

Objectives: We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). Background: Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. Methods: A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received <1 assigned study stent), powered for noninferiority. Results: The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, pnoninferiority = 0.001, psuperiority = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). Conclusions: In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. (A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of up to Two De Novo Coronary Artery Lesions: NCT00823212) © 2011 American College of Cardiology Foundation.


Kandzari D.E.,Piedmont Heart Institute | Leon M.B.,Columbia University Medical Center | Meredith I.,Monash University | Fajadet J.,Clinique Pasteur | And 2 more authors.
JACC: Cardiovascular Interventions | Year: 2013

Objectives: The aim of this study was to evaluate late safety and efficacy outcomes among patients enrolled in clinical trials comparing Endeavor zotarolimus-eluting stents (E-ZES) (Medtronic, Inc., Santa Rosa, California) with first-generation drug-eluting stents (DES) and bare-metal stents (BMS). Background: Despite demonstration of higher angiographic luminal loss and restenosis with E-ZES compared with alternative DES, whether differences in these early angiographic measures translate into more disparate late clinical events is uncertain. Methods: Among 3,616 patients undergoing percutaneous coronary revascularization in 5 registration trials, late safety and efficacy events were compared between E-ZES (n = 2,132) versus sirolimus- or paclitaxel-eluting stents (n = 888) or BMS (n = 596). Results: Compared with a parallel cohort of patients treated with first-generation DES and BMS, 5-year rates of cardiac death/myocardial infarction (MI) (5.8% vs. 8.8% DES, p = 0.003; vs. 8.4% BMS, p = 0.02) and major adverse cardiac events (16.1% vs. 20.6% DES, p = 0.009; vs. 24.6% BMS, p < 0.001) were significantly lower with E-ZES. The E-ZES was associated with significantly lower target lesion revascularization (TLR) compared with BMS (7.4% vs. 16.3%, p < 0.001) but similar to comparator DES (7.4% vs. 8.1%, p = 0.63). Despite higher TLR in the first year with E-ZES compared with DES, between 1- and 5-year follow-up, rates of cardiac death/MI, TLR, and definite/probable stent thrombosis were significantly lower with E-ZES. Conclusions: Over 5 years, significant differences in cardiac death/MI and composite endpoints favored treatment with E-ZES over comparator BMS and DES. Rates of clinical restenosis and safety events, including stent thrombosis beyond the first year of revascularization, remain stable with E-ZES, leading to significant differences compared with first-generation DES. © 2013 American College of Cardiology Foundation.


Kandzari D.E.,Piedmont Heart Institute | Barker C.S.,University of Houston | Leon M.B.,Columbia University | Mauri L.,Brigham and Women's Hospital | And 3 more authors.
JACC: Cardiovascular Interventions | Year: 2011

Objectives: We sought to evaluate differences in late safety outcomes relative to dual antiplatelet therapy (DAPT) duration in patients treated with zotarolimus-eluting stents (ZES). Background: Despite treatment recommendations for at least 12 months of DAPT following drug-eluting stent revascularization, device-specific outcomes relative to DAPT duration are absent. Methods: Among 2,032 patients undergoing percutaneous coronary revascularization with ZES in 5 trials, late safety events were compared relative to DAPT duration for patients with <6 months DAPT adherence and survival free of major ischemic and bleeding events. Results: A total of 1,414 event-free patients on DAPT at 6 months were identified. Patient group comparisons relative to DAPT included: 6 months versus <12 months, and 6 months versus ≥24 months. Through 3 years, risk-adjusted ischemic event rates did not significantly differ between groups: 6 versus ≥12 months: death (2.7% vs. 2.2%), myocardial infarction (MI, 0.3% vs. 1.1%), and definite/probable stent thrombosis (ST, 0.3% vs. 0%); 6 versus ≥24 months: death (1.6% vs. 1.6%), MI (0.4% vs. 1.2%), and definite/probable ST (0.1% vs. 0.2%). Composite events also did not statistically vary between DAPT durations. In multivariable analysis, 6-month versus longer DAPT duration was not associated with increased likelihood of thrombotic events at 3-year follow-up. Major bleeding was negligible across groups. Conclusions: Among patients treated with ZES, late-term events of death, MI, stroke, and ST do not significantly differ between patients taking 6 months DAPT compared with continuation beyond 1 year. These findings merit further study to identify the appropriate duration of DAPT according to specific drug-eluting stents. © 2011 American College of Cardiology Foundation.


Fajadet J.,Clinique Pasteur | Chieffo A.,San Raffaele Scientific Institute
European Heart Journal | Year: 2012

Coronary artery bypass surgery is considered as the gold standard treatment of unprotected left main coronary artery (ULMCA) disease. Over the last 20 years, improvement in stent technology and operators experience explained the increased number of reports on the results of percutaneous coronary interventions (PCIs) for the treatment of left main (LM) coronary artery lesion. The recent data comparing efficacy and safety of PCIs using drug-eluting stent and coronary artery bypass surgery showed comparable results in terms of safety and a lower need for repeat revascularization for coronary artery bypass surgery. Patient selection for both techniques is fundamental and directly impacts the clinical outcome. Further randomized trials must be conducted to precise the indications of both techniques of revascularization in the treatment of LM disease. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2011.

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