Feature | October 31, 2013

Global Bifurcation Leader Tryton Medical Announces Events at TCT 2013

First results from the Tryton Side Branch Stent Pivotal IDE Trial presented in Late Breaking Clinical Trial session

stents biforcation clinical trial study cath lab tryton tct side branch
October 31, 2013 — Tryton Medical Inc., a developer of stents designed to treat bifurcation lesions, announced activities highlighting the latest data and experience with the Tryton Side Branch Stent at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (TCT 2013).
Martin Leon, M.D. and principal investigator of the study, presented the first results from the Tryton Side Branch Stent Pivotal IDE trial during the morning Late Breaking Clinical Trial session.
The Tryton Pivotal IDE trial was an international, randomized study that compares a Tryton Stent in the side branch to conventional provisional stenting (balloon angioplasty) in the side branch, with both study groups receiving a standard drug-eluting stent (DES) in the main vessel. The study, which is the first randomized U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal clinical trial to evaluate a dedicated bifurcation stent, enrolled 704 patients at 67 centers in North America and 11 countries throughout Europe and Israel. It is the largest coronary bifurcation study ever conducted and the first study to employ core lab angiographic (3-D and planar) and intravascular ultrasound (IVUS) analysis. 
In advance of the unveiling of the results from this first-in-class trial, Leon presented Left Main and Bifurcation Stenting: An Advanced Operator’s Workshop during Session VIII on Dedicated Bifurcation Stents. He presented on the topic of “The Case for Dedicated Bifurcation Stents; Device and Regulatory Landscape; and Anticipation of the Pivotal Tryton Results.”
Leon and Patrick Serruys, M.D. and Ph.D., chaired a symposium regarding the Tryton Side Branch Stent. At the symposium, clinicians further examined the clinical and angiographic outcomes from the IDE trial, reviewed the historic body of clinical evidence, presentred real-world Tryton Stent cases and provided perspectives on treating a broad spectrum of bifurcation anatomies. 
Additionally, the Tryton Stent was featured in the Challenging Cases forum and in Poster Abstract sessions:
  • Robin Kraak, M.D., hosted: “Treatment of complex coronary bifurcation lesion; ABSORB BVS in combination with Tryton short dedicated bifurcation stent” and “Treatment of complex coronary bifurcation lesion in a patient with acute ST elevation myocardial infarction; ABSORB BVS in combination with Tryton dedicated bifurcation stent.”
  • Balazs Berta, M.D., hosted “Trifurcational occlusion treated by dedicated bifurcation stent in ST-elevation myocardial infarction from transradial approach.”
  • Maik Grundeken, M.D., hosted “First Report on Long-term Clinical Results After Treatment of Coronary Bifurcation Lesions With the Tryton Dedicated Bifurcation Stent.”
For more information: www.trytonmedical.com

Related Content

Feature | Stents Bioresorbable| October 20, 2016 | Dave Fornell
There has been a lot of interest in the interventional community regarding the Abbott Absorb Bioresorbable Vascular S
Avinger, Pantheris atherectomy catheter, OCT, Lumivascular technology, expanded FDA indication, diagnostic imaging device
News | Atherectomy Devices| October 20, 2016
Avinger Inc. recently announced that the company has received expanded indications from the U.S. Food and Drug...
St. Jude Medical, ADO II AS trial, congenital heart disease, PDA, Amplatzer Duct Occluder II AS
News | Congenital Heart| October 19, 2016
St. Jude Medical Inc. announced the launch of the ADO II AS (AMPLATZER Duct Occluder II Additional Sizes) pediatric...
recall, alligator retrieval device, X-Celerator hydrophilic guidewire, UltraFlow flow directed micro catheters, Marathon flow directed micro catheters
News | Cath Lab| October 18, 2016
Medtronic plc announced last week that it has notified customers of a voluntary recall of certain lots of its Pipeline...
Inventory management, Cardinal, RFID inventory tracking, cath lab inventory
Sponsored Content | Whitepapers | Inventory Management| October 18, 2016
As healthcare moves into the era of bundled payments, providers need to be especially focused on ensuring delivery of
angioseal, angio-seal, terumo, St. Jude, vascular closure devices
News | Vascular Closure Devices| October 18, 2016
October 18, 2016 — Abbott and St. Jude Medical Inc.
Lantheus, flurpiridaz F-18, myocardial perfusion imaging, MPI, cardiac stress testing, ASNC 2016
News | Radiopharmaceuticals and Tracers| October 17, 2016
Lantheus Holdings Inc. announced in late September that sub-analysis data from the first Phase 3 study of flurpiridaz F...
Medtronic, FIRE AND ICE trial, Arctic Front, cryoballoon catheter ablation, radiofrequency RF ablation, study results, Asia Pacific Heart Rhythm Society Scientific Sessions
News | Ablation Systems| October 17, 2016
Medtronic plc last week unveiled new health economic analysis data from the FIRE AND ICE trial that favor cryoballoon...
transcarotid artery revascularization, TCAR Surveillance Project, Society for Vascular Surgery Patient Safety Organization, SVS PSO,
News | Stents Carotid| October 13, 2016
A surveillance project to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) in...
3-D bioprinting, 3-D printing, printed organs, 3D bioprinting

3-D printed vessel made from living cells implanted in an animal to test feasibility of using such structures clinically. Blood vessels are a stepping stone to the creation of more complex 3-D printed organs made from biomaterials. Image from the South Carolina Project for Organ Biofabrication.


Feature | 3-D Printing| October 13, 2016 | Dave Fornell
The U.S. Food and Drug Administration (FDA) changed its rules concerning custom medical devices Oct.
Overlay Init