TOP Medical - To Optimize Performance | Latest news http://www.top-medical.com/ The latest news around TOP Medical - To Optimize Performance nl Copyright 2012, TOP Medical info@top-medical.com info@top-medical.com TOP Medical to attend Complex PCI, Left Main and CTO Summit in New York http://www.top-medical.com/news//2012/02/20/top-medical-to-attend-complex-pci-left-main-and-cto-summit-in-new-york/ TOP Medical will attend the Complex PCI, Left Main and CTO Summit in New York from February 23-25th.

Please visit us at the Asahi Intecc booth.

 

 

]]> Mon, 20 Feb 2012 00:00:00 +0100 TOP Medical receives award for Outstanding Performances in 2011 http://www.top-medical.com/news//2012/01/30/top-medical-receives-award-for-outstanding-performances-in-2011/ TOP Medical received an award from Shawn P. McCarthy, President & CEO of Tryton Medical for an Outstanding Sales and Clinical Support Performance in 2011.

Tryton’s innovative solution to the persistent problem presented by bifurcation lesions is the Tryton Side Branch Stent System™.

The Tryton Side Branch Stent System is designed to treat a wide spectrum of bifurcated lesions. The system’s highly deliverable stent is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug eluting stent is then placed in the main vessel.

The Side Branch Stent features a low-profile cobalt chromium design compatible with 5F guide catheters. The stent’s unique three-zone design provides superior scaffolding within the side branch, radial strength in the transition zone, and minimal coverage in the main vessel zone.

This unique system has demonstrated excellent initial clinical results and is available for sale in Europe. TOP Medical has the exclusive distribution rights for the Netherlands, Belgium and Luxemburg.

 

]]> Mon, 30 Jan 2012 00:00:00 +0100 TOP Medical to Launch the Cre8 Polymerfree Drug Eluting Stent http://www.top-medical.com/news//2012/01/02/top-medical-to-launch-the-cre8-polymerfree-drug-eluting-stent-/ TOP Medical is pleased to announce that its launching the Cre8 Polymer Free Drug Eluting Stent of CID.  

The Cre8TM polymer-free DES embodies the most advanced DES technologies to treat coronary vascular disease. Its unique distinctive features - Abluminal Reservoir Technology, Amphilimus Formulation and Bio Inducer Surface - make Cre8TM the only very effective Polymer-Free DES today available. In the NEXT study, an international prospective randomized clinical trial, it resulted being statistically superior to TAXUSTM Libertè with respect to in-stent late lumen loss (0.14 mm Cre8TM vs. 0.34 mm Taxus, p<0.0001).

The proprietary Abluminal Reservoir Technology (ART) provides a consistent drug loading onto the stent platform, thus enabling a controlled and directed elution exclusively targeted to the vessel wall. The innovative Amphilimus™ formulation, that is Sirolimus formulated with an organic acid, is the first known use of a carrier to enhance drug bioavailability and drug distribution to the entire vessel wall. The Bio Inducer Surface, a second generation integral pure carbon coating, demonstrates excellent results in terms of stent endothelialization and struts coverage. The use of the Bio Inducer Surface onto the Cre8TM Polymer-Free DES enables faster DES endothelialisation and reduces device thrombogenicity risk.

“We develop our stents with the objective of providing patients the best possible clinical outcome in terms of both efficacy and safety. We believe that Cre8TM represents an important achievement for the interventional cardiologist community, as it is a DES that has none of the drawbacks associated with polymers. In addition, because of the Bio Inducer Surface and Abluminal Reservoir Technology, we hope that physicians will be able to shorten the dual antiplatelet therapy period for their patients and reduce the high cost of care as well as the side effects of these drugs.” said Franco Vallana, President and C.E.O. of CID SpA.

 

]]> Mon, 02 Jan 2012 00:00:00 +0100 TOP Medical to sell Kimberly-Clark Pain Management Product Line http://www.top-medical.com/news//2012/01/01/top-medical-to-sell-kimberly-clark-pain-management-product-line/ TOP Medical is pleased to announce that it has entered into an agreement with Kimberly-Clark to distribute its Pain Management Product Line in the Netherlands, as of January 1st, 2012. 

 

Kimberly-Clark has a worldwide reputation with high quality products and continuous innovation, including a wide range of products for standard, pulsed and multi-level RF-denervation techniques. Also products for the unique Cooled RF denervation technique are part of the product portfolio. 

TOP Medical is proud to partner with Kimberly-Clark and support them in reaching their goals within Europe and beyond

 

]]> Sun, 01 Jan 2012 00:00:00 +0100 Cameron Health announced 1,000th S-ICD Implant http://www.top-medical.com/news//2011/12/16/cameron-health-announced-1000th-s-icd-implant/ Cameron Health, Inc. announced that the 1,000th patient was recently implanted with the S-ICD® System, the world’s only completely subcutaneous implantable defibrillator. Of these 1,000 patients more than 25% has been implanted in the Netherlands supported by TOP Medical.  The 1,000th patient was implanted by Lara Dabiri Abkenari, M.D., in association with Professor Luc Jordaens, M.D., Ph.D., at the Erasmus Medical Center in Rotterdam, the Netherlands. Professor Jordaens remarked, “We have gained significant insight into this new technology over the past two years and are encouraged by the results. The avoidance of transvenous lead placement has significant implications for both short and long-term complication rates.” "Our experience with these first 1,000 patients has confirmed that the S-ICD System is a valuable new treatment option for both primary and secondary prevention patients at risk of sudden cardiac arrest. In addition, the S-ICD System provides an important alternative for patients that are not candidates for conventional transvenous ICD systems,” said Kevin Hykes, Cameron Health’s President and CEO. “The S-ICD System has the inherent advantage of not requiring an electrode inside of the heart,” said Reinoud Knops M.D., at the Amsterdam Medical Center, the Netherlands. “It will be important to investigate how the less-invasive approach of the S-ICD System will impact the rate of serious complications in comparison to traditional transvenous ICD systems.” In order to evaluate the performance of the S-ICD System in the real-world setting, Cameron Health recently initiated the EFFORTLESS™ Registry in Europe and New Zealand. EFFORTLESS will follow the S-ICD System in 1,000 patients for a period of 60 months post implant. In the US, Cameron Health plans to submit clinical data from its recently completed, 330-patient S-ICD System Pivotal IDE Clinical Study to the FDA in early 2012. 

]]> Fri, 16 Dec 2011 00:00:00 +0100 TOP Medical expands business with new Neuro Therapies Division http://www.top-medical.com/news//2011/11/11/top-medical-expands-business-with-new-neuro-therapies-division/ TOP Medical is pleased to announce that it expands its successful business model with a Neuro Therapies Division. This new Division is founded together with Kees Ruck who worked 12 years for Medtronic of which 7 years as Business Manager for the Neuro Division. As Director Neuro Therapies Kees will be responsible to grow and develop this Division in line with the strategic objectives of TOP Medical. More TOP Medical Neuro Therapies news will be announced shortly!

]]> Fri, 11 Nov 2011 00:00:00 +0100 Study shows that Baylis RF Needle Improves Safety and Efficacy of Transseptal Puncture http://www.top-medical.com/news//2011/09/16/study-shows-that-baylis-rf-needle-improves-safety-and-efficacy-of-transseptal-puncture/ TOP Medical is share the results of the study of Dr. Winkle published in Hearth Rhythm. The use of a radiofrequency (RF) needle improves the speed, efficacy, and safety of trans-septal catheterization in patients undergoing ablation of the left atrium for atrial fibrillation (AF). These are the findings from a single-center study published in Heart Rhythm. “The introduction of the RF trans-septal needle represents the first major equipment advance for trans-septal puncture in almost 50 years,” write the investigators. “We had done a large number of trans-septal punctures using standard needles,” says Dr Roger Winkle, who led the study. “It was always an uncomfortable procedure and we were on the look-out for better and safer tools.” The NRG® RF trans-septal needle was developed by Baylis Medical (Saint‑Laurent, Canada) and was used by the investigators for a series of 575 AF ablations. The outcomes of these procedures were compared with the researchers’ previous experience of using standard BRK™ trans-septal needles (St Jude Medical, Maple Grove, USA) for 975 ablation procedures. Among the 1,167 patients who underwent AF ablation with either of the two needles, the most prevalent rhythm abnormality was persistent AF (52.9%). The NRG® needle had a significantly lower failure rate for transseptal puncture than the standard needle (0.17% vs 1.23%, P = 0.039). The only case in which the RF needle failed to perforate the septum was in a patient with hypertrophic cardiomyopathy. None of the patients undergoing ablation with the RF needle experienced pericardial tamponade, compared with nine of those whose procedure involved the use of the standard needle (P = 0.031). “We hope our work will stimulate others to adopt the new RF technology,” concludes Dr Winkle. “It should reduce complications from AF ablation and other procedures that require left atrial entry.” Original article Winkle, R. A., Mead, R. H., Engel, G. & Patrawala, R. A. The use of a radiofrequency needle improves the safety and efficacy of trans-septal puncture for atrial fibrillation ablation. Heart Rhythm doi:10.1016/ j.hrthm.2011.04.032 

]]> Fri, 16 Sep 2011 00:00:00 +0200 TOP Medical signs exclusive agreement with Toray International to distribute the Inoue-Balloon http://www.top-medical.com/news//2011/07/07/top-medical-signs-exclusive-agreement-with-toray-international-to-distribute-the-inoue-balloon/ TOP Medical is pleased to announce the exclusive agreement with Toray International to distribute the Inoue-Balloon in the Benelux.

Developed for the treatment of mitral valve stenosis, the Inoue-Balloon Catheter is indicated for Percutaneous Transvenous Mitral Commissurotomy (PTMC) in patients with hemodynamically significant mitral valvular stenosis, resulting primarily from commissural fusion of the mitral valve cusps.

Published data from observational and randomized studies have provided evidence that physicians should consider PTMC as a treatment choice for patients with favorable valve anatomy.The PTMC procedure is one of several methods for treating symptomatic mitral stenosis. Alternative methods which may be considered include: medical therapy, surgical commissurotomy, mitral valve repair and mitral valve replacement.

]]> Thu, 07 Jul 2011 00:00:00 +0200 TOP Medical launches the ASAHI SION, a New Generation Workhorse Wire with a 3D Torque Revolution http://www.top-medical.com/news//2011/07/01/top-medical-launches-the-asahi-sion-a-new-generation-workhorse-wire-with-a-3d-torque-revolution/ Nuth, July 2011; TOP Medical is pleased to announce the launch of the ASAHI SION, a New Generation Workhorse Wire with a 3D Torque Revolution.

Asahi Intecc has succeeded in developing a guide wire with 1:1 torque transmission in 3 dimension vessel anatomy, which has never before been accomplished.

This development facilitates your daily PCI practice as well as complex cases via acute angled vessel anatomies. The unique tip structure provides excellent shaping memory and durability, making multi-vessel treatments possible without changing wires.Witness of ASAHI SION’s 3D Torque Revolution.

]]> Fri, 01 Jul 2011 00:00:00 +0200 Tryton Announces CE Mark for Larger-Diameter Sizes of Side Branch Stent. http://www.top-medical.com/news//2011/06/09/tryton-announces-ce-mark-for-larger-diameter-sizes-of-side-branch-stent/ Tryton Announces CE Mark for Larger-Diameter Sizes of Side Branch Stent. New Sizes Will Allow Physicians to Treat Broader Group of Patients with Bifurcation Disease Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced receipt of CE Mark for larger-diameter sizes of the Tryton Side Branch Stent System™ for the treatment of coronary artery disease. Launch of the larger diameter size stents, 3.0 to 3.5mm and 3.5 to 4.0mm, has begun in Europe. The new sizes are designed for larger coronary vessels. “Tryton’s Side Branch Stent System is an innovative solution to this persistent problem with impressive acute and long-term clinical outcomes. I am pleased that the launch of larger sizes of the Tryton Stent System will enable me to treat additional patients with bifurcations disease.”  “Current treatments for bifurcations have significant limitations, including higher rates of thrombosis – potentially fatal blood clots – and restenosis,” said Prof. Robert Van Geuns, associate professor, Erasmus Medical Center, Rotterdam, Netherlands. “Tryton’s Side Branch Stent System is an innovative solution to this persistent problem with impressive acute and long-term clinical outcomes. I am pleased that the launch of larger sizes of the Tryton Stent System will enable me to treat additional patients with bifurcations disease.” “With nearly 3,000 patients now treated and our randomized, multi-center pivotal trial enrolling patients in the United States, we continue to see positive momentum for the Tryton Side Branch Stent System,” said Rick Anderson, board member of Tryton and managing director of PTV Sciences. “We are pleased that we have been able to respond to physicians’ requests for larger-diameter sizes of the device, enabling them to treat a larger portion of their patients with bifurcation disease.” Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these lesions are time consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation. Bifurcation lesions account for as many as one-third of all coronary lesions.1 About the Tryton Side Branch Stent The Tryton Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. Tryton’s cobalt chromium stent is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel. Clinical results from more than 500 patients with bifurcation lesions have consistently demonstrated target lesion revascularization (TLR) rates of less than four percent.  TOP Medical is the Exclusive Distributor for the Netherlands, Belgium and Luxembourg.

 

]]> Thu, 09 Jun 2011 00:00:00 +0200