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Abbott’s Bioabsorbable Stent met its Primary Endpoint in a U.S. Clinical Trial, applications for FDA Approval follows

Reporter: Aviva Lev-Ari, PhD, RN

 

Absorb device is designed to fully dissolve after delivering its anti-restenosis drug payload, unlike conventional drug-eluting stents what leave behind a metal scaffold.

 

TCT 2015: Abbott’s Absorb meets endpoint in U.S. pivotal trial

One-year data from the Absorb III trial of 2,008 patients showed that the Absorb device was non-inferior to Abbott’s flagship Xience drug-eluting stent. The Absorb device is designed to fully dissolve after delivering its anti-restenosis drug payload, unlike conventional drug-eluting stents what leave behind a metal scaffold.

The trial showed a rate of target lesion failure of 7.8% for the Absorb arm and 6.1% for the Xience arm and no significant difference in rates of cardiac death (0.6% for the Absorb stent and 0.1% for the Xience stent); target vessel myocardial infarction (6.0% and 4.6%, respectively); or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively. Device thrombosis occurred in 1.5% of Absorb patients and 0.7% of Xience patients, according to the study, which was also published in the New England Journal of Medicine.

“The Absorb III data shows that there are no statistically significant 1-year differences between Absorb and Xience, which is a major accomplishment given Xience’s strong performance as the current standard of care,” co-principal investigator Dr. Dean Kereiakes of Cincinnati’s Christ Hospital Heart & Vascular Center said in prepared remarks. “Naturally dissolving heart stents are the next revolution in percutaneous coronary intervention, and Absorb is leading the way as an innovative option. Absorb does its job and then restores the vessel to its natural state over time, which cannot be achieved with a permanent drug eluting stent.”

During a press conference discussing the results, Kereiakes cited Absorb’s performance in the context of a 1st-generation device going up against what he called the “gold standard” in Xience.

“The remarkable thing is that a gen-1 device really goes toe to toe [with Xience],” he said. “Longer-term evaluation is ongoing to determine if Absorb improves late outcomes compared with Xience.”

Asked about the value proposition for Absorb versus Xience, Dr. Daniel Simon of Cleveland’s Harrington Heart & Vascular Institute said providers are usually willing to pay a little more for new technologies.

“In medicine, in general, when you have technological iterations and innovations, one tends to pay more,” Simon said, noting that . “Health systems allow for companies to make fair profit, [in order] to have advances in medicine. … The long and the short of it is, we’ll pay a little more for a device that patients are asking for.”

Data from 2 other studies presented today at TCT 2015, Absorb II and Absorb China, also showed that the Absorb device functions similarly to Xience.

“The trial met all its major endpoints, and given all the attributes my opinion is that it should be approvable,” said Dr. Gregg Stone of New York’s Columbia University Medical Center, global chairman of the study. “We’ve got good reason to be very hopeful that the long-term outcomes for patients will be improved with this device compared with a normal metallic drug-eluting stent.

“A lot of patients would much rather have a dissolving stent that returns arteries back to their normal condition,” Stone said. “It will be very good for young patients who will live 30 or 40 years with this decision.”

“Results of the Absorb III pivotal trial show that Absorb is comparable to the best-in-class metallic stent. However, because Absorb leaves nothing behind it may provide significant longterm benefits, such as a restored vessel in a natural state and renewed possibilities for people treated with Absorb,” added Abbott vice president Dr. Charles Simonton in a press release. “At Abbott we will continue to study Absorb in our robust clinical trials to show the long-term benefits of Absorb that differentiate it from permanent, metallic stents.”

Material from Reuters was used in this report.

SOURCE

http://www.massdevice.com/tct-2015-abbotts-absorb-meets-endpoint-in-u-s-trial/?utm_source=newsletter-151013

 

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Fractional Flow Reserve vs. Angiography in Non-ST-segment Elevation Myocardial Infarction

Reporter: Aviva Lev-Ari, PhD, RN

 

Jamie Layland, Keith G. Oldroyd, Nick Curzen, Arvind Sood, Kanarath Balachandran, Raj Das, Shahid Junejo, Nadeem Ahmed, Matthew M.Y. Lee, Aadil Shaukat, Anna O’Donnell, Julian Nam, Andrew Briggs, Robert Henderson, Alex McConnachie, Colin Berry

Disclosures

Eur Heart J. 2015;36(2):100-111. 

Aim

We assessed the management and outcomes of non-ST segment elevation myocardial infarction (NSTEMI) patients randomly assigned to fractional flow reserve (FFR)-guided management or angiography-guided standard care.

Methods and results

We conducted a prospective, multicentre, parallel group, 1 : 1 randomized, controlled trial in 350 NSTEMI patients with ≥1 coronary stenosis ≥30% of the lumen diameter assessed visually (threshold for FFR measurement) (NCT01764334).

Enrolment took place in six UK hospitals from October 2011 to May 2013. Fractional flow reserve was disclosed to the operator in the FFR-guided group (n 1/4 176). Fractional flowreserve was measured but not disclosed in the angiography guided group (n 1/4 174). Fractional flowreserve ≤0.80was an indication for revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). The median (IQR) time from the index episode of myocardial ischaemia to angiographywas 3 (2, 5) days. For the primary outcome, the proportion of patients treated initially by medical therapy was higher in the FFR-guided group than in the angiography-guided group [40 (22.7%) vs. 23 (13.2%), difference 95% (95% CI: 1.4%, 17.7%), P 1/4 0.022]. Fractional flow reserve disclosure resulted in a change in treatment between medical therapy, PCI or CABG in 38 (21.6%) patients. At 12 months, revascularization remained lower in the FFR-guided group [79.0 vs. 86.8%, difference 7.8% (20.2%, 15.8%), P 1/4 0.054]. There were no statistically significant differences in health outcomes and quality of life between the groups.

Conclusion

In NSTEMI patients, angiography-guided management was associated with higher rates of coronary revascularization compared with FFR-guided management. A larger trial is necessary to assess health outcomes and cost-effectiveness.

SOURCE

 

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AGENDA – ICI Conference – Innovation in Cardiovascular Interventions – December 14-16, at the David InterContinental Hotel, Tel Aviv, Israel

Reporter: Aviva Lev-Ari, PhD, RN

 

1. ICI Scientific Program

ICI2014 speakers are some of the leading figures in the field. The preliminary list can be viewed at the ICI website.

ICI2014 will hold for the second time the “Wall to Wall Session – From the Great Wall of China to the Jerusalem Wall”. Click here for a glance at the 2013 program endorsed by Yanping Gao, the Chinese Ambassador in Israel.

Attendees will:

 Be exposed to promising research and new therapies in various phases of development.

 Learn from live case presentations on the impact of emerging technologies on current and future therapies.

 Gain insights from international experts speaking on important clinical topics—with an emphasis on future perspectives.

2. ICI Exhibition

The heart of the ICI Meeting is the strong International collaboration between Medicine and Industry. With an emphasis on technological developments, novel knowledge-rich technologies, and the diligent pursuit of solutions to yet unsolved problems in heart, brain and cardiovascular medicine, the ICI meeting features a State-of-the-Art Exhibition and Innovative Technology Parade.

Since 1995, the ICI exhibition is rapidly growing with more than 90 international exhibitors and sponsors, including the strongest players in the market alongside cutting edge innovative startups. ICI Exhibition is the perfect opportunity to connect and interact with the people that can affect the future of this field.

3. ICI Technology Parade

Focused on innovation, ICI provides an extensive platform for startup companies presenting their latest technologies. The Technology Parade can be a springboard for new companies with bright and creative new ideas. This is the perfect opportunity to help your business move “from idea to reality”. The Technology Parade Sessions enjoy a tremendous success in every meeting, attracting a wide variety of leading clinicians, scientists and corporate representatives. The wide spectrum of investors who will be in attendance will find the ICI Meeting a valuable forum for exposure to the development and advancement of innovative ideas in cardiology.

The ICI meeting is a tremendous opportunity to review the most innovative startups in the field of medical devices and meet in person at the B2B area. This event can be your chance to look into the latest most prominent investments opportunity. 

SOURCE

http://2014.icimeeting.com/

Conference PROGRAM

http://2014.icimeeting.com/ici-2014-program/

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Tethered–Liquid Perfluorocarbon surface (TLP): Biocoating Prevents Blood from Clotting on Implantables

Reporter: Aviva Lev-Ari, PhD, RN

 

 

VIEW VIDEO

http://www.mdtmag.com/news/2014/10/biocoating-prevents-blood-clotting-implantables?et_cid=4205834&et_rid=461755519&type=cta

Wyss Institute researchers discuss how they used FDA-approved materials to develop a slippery coating that can be applied to medical devices to prevent blood clotting and bacteria accumulation. (Credit: Harvard’s Wyss Institute)

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Titanium-nitric-oxide-coated bioactive stents in acute coronary syndrome

Reporter: Larry Bernstein, MD, FCAP

SOURCE: http://www.researchgate.net/publication/256607204_Stent-oriented_versus_patient-oriented_outcome_in_patients_undergoing_early_percutaneous_coronary_intervention_for_acute_coronary_syndrome_2-year_report_from_the_BASE-ACS_trial

REBLOG

Titanium-nitric-oxide-coated bioactive stents in acute coronary syndrome: towards a more clear landscape!

 Assisstant Professor of Cardiology, Faculty of Medicine, Ain Shams University, Egypt

With full interest, we read the Editorial “Nitric-oxide Coated Bioactive Titanium Stents: Safer and More Effective Than Second-generation Drug-eluting Stents?” by Sabaté et al 1. I’d like to commend the authors for publishing this interesting analysis of recently published studies – including the BASE ACS randomized controlled trial– comparing titanium-nitric-oxide-coated bioactive stents (NO-BAS) with drug-eluting stents. Yet, since I’m one of the authors of the BASE ACS trial, I’d like to clarify some points. First, the BASE ACS trial was adequately powered to detect a difference of the primary composite endpoint at 12 months (827 patients), with a formal statistical power calculation 2. Second, as the authors reported, the NO-BAS were non-inferior to cobalt-chromium-based everolimus-eluting stents (EES) for the primary composite endpoint of major adverse cardiac events (MACE) that included cardiac death, non-fatal myocardial infarction (MI), and ischemia-driven target lesion revascularization, in patients presenting with the full spectrum of acute coronary syndrome at 12-month follow-up 2. The 12-month rates of the individual secondary endpoints of non-fatal MI and definite stent thrombosis (ST) were lower in patients who received NO-BAS versus those who received EES (2.2% versus 5.9%, and 0.7% versus 2.2%, p= 0.007 and 0.07, respectively) 3. And whereas the definition of MI adopted by the BASE ACS trial (based on CK MB or troponin ≥2 times the upper reference limit) was different from that employed in the EXAMINATION trial (extended definition of the World Health Organization), it cannot be held responsible for the difference in MI rates between NO-BAS and EES in the same BASE ACS trial, since the definition was equally applied to the two trial arms 2,3. Third, the early (within 30 days) divergence of safety endpoints between the 2 stent arms is hard to explain merely in view of peri-procedural bivalirudin monotherapy. In fact, out of 9 cases (2.2%) of definite ST in the EES arm, 3 were acute (within 24 hr); out of these 3, only 2 received peri-procedural bivalirudin as a sole anticoagulant 2. Moreover, peri-procedural bivalirudin use was comparable between the 2 stent arms: 14.1% versus 15.1% in NO-BAS versus EES arms, respectively. Furthermore, angiographic success was achieved in 99.8% in both stent arms; hence, technical issues (distal dissection, stent underexpansion) were probably similar in the 2 stent arms 2. More importantly, the rates of non-fatal MI and definite ST continued to diverge after one year: at 2-year follow-up, they were 2.9% versus 7.1%, and 1.0% versus 2.7%, p= 0.005 and 0.05, for NO-BAS versus EES, respectively 4. Since technical issues generally operate early (within 1 month) after stent implantation; therefore, they cannot fully account for the ‘very late’ events. References

1. Sabaté M, Brugaletta S. Nitric-oxide Coated Bioactive Titanium Stents: Safer and More Effective Than Second-generation Drug-eluting Stents? Rev Esp Cardiol. 2014;67:511-3. 2. Karjalainen PP, Niemela M, Airaksinen KEJ, et al. A prospective randomized comparison of titanium-nitride-oxide-coated bioactive stents with everolimus-eluting stents in acute coronary syndrome: the BASE-ACS trial. EuroIntervention. 2012;8:1769–74. 3. Sabate M, Cequier A, In˜iguez A, et al. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012;380:1482–90. 4. Romppanen H, Nammas W, Kervinen K, et al. Stent-oriented versus patient-oriented outcome in patients undergoing early percutaneous coronary intervention for acute coronary syndrome: 2-year report from the BASE-ACS trial. Ann Med. 2013;45:488-93.

additional:

 Pooled Analysis of Two Randomized Trials Comparing Titanium-nitride-oxide-coated Stent Versus Drug-eluting Stent in STEMI. Petri O. Tuomainenab, Jussi Siac, Wail Nammasb, Matti Niemeläd, Juhani K.E. Airaksinene, Fausto Biancarif, Pasi P. Karjalainen. Rev Esp Cardiol. 2014;67(7):531-7  http://dx.doi.org:/10.1016/j.rec.2014.01.024

KeywordsBioactive stents. Everolimus-eluting stents. Paclitaxel-eluting stents. ST-segment elevation myocardial infarction. Outcome.

Pooled Analysis of Two Randomized Trials Comparing Titanium-nitride-oxide-coated Stent Versus Drug-eluting Stent in STEMI

Petri O. Tuomainenab, Jussi Siac, Wail Nammasb, Matti Niemeläd, Juhani K.E. Airaksinene, Fausto Biancarif, Pasi P. Karjalainenb, a Department of Internal Medicine and Heart Center, Kuopio University Hospital and University of Eastern Finland, Kuopio, Finland b Department of Cardiology, Satakunta Central Hospital, Pori, Finland c Department of Cardiology, Kokkola Central Hospital, Kokkola, Finland d Department of Internal Medicine, Division of Cardiology, University of Oulu, Oulu, Finland e Department of Medicine, Turku University Hospital, Turku, Finland f Division ofCardiothoracic and Vascular Surgery, Department of Surgery, Oulu, Finland

Refers to

Keywords

Bioactive stents. Everolimus-eluting stents. Paclitaxel-eluting stents. ST-segment elevation myocardial infarction. Outcome.

Abstract

Introduction and objectivesWe performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. MethodsThe TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. ResultsThe pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P = .49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P = .51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P = .04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P = .30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. ConclusionsIn patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar.

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