News | October 31, 2013

Amaranth Medical Reports Positive Safety, Feasibility for the Fortitude Bioresorbable Scaffold

stents bioresorbable fortitude amaranth
October 31, 2013 — Amaranth Medical presented positive six-month angiographic results from its first-in-human study of its fully bioresorbable stent in patients undergoing percutaneous coronary intervention (PCI) with single coronary lesions. 
 
The Fortitude non-drug eluting bioresorbable scaffold was successfully delivered in 12 patients within the target lesion. Post-deployment angiographic and intravascular ultrasound (IVUS) analysis indicated that the Fortitude scaffold maintained its mechanical integrity, showing no indication of vessel recoil or other structural failures. At the time of the presentation, 10 patients had completed six-month angiographic follow up and six patients had available independent angiographic analysis indicating 0 percent binary restenosis. The data was presented at the "Next generation DES and bioabsorbable scaffolds" session at the Transcatheter Cardiovascular Therapeutics Annual Conference (TCT 2013) on Oct. 27 in San Francisco.
 
"Short-term failure of bioresorbable stents is often a result of a device's inability to withstand the biomechanical challenges imposed by the atherosclerotic plaque resulting in recoil and restenosis,” said Kamal Ramzipoor, general manager and chief technical officer, Amaranth. “The Fortitude scaffold has shown high mechanical strength and significant durability during the first six months, which is key to successful vessel remodeling. Importantly, the proprietary materials that provide Fortitude's mechanical integrity also allow it to be entirely bioresorbable, thus potentially restoring vascular physiology reducing the risk of late stent thrombosis and improving long-term clinical outcomes."
 
Six-month angiographic follow-up data is available on 10 of the 13 patients enrolled in the first cohort and demonstrate excellent biomechanics and biocompatibility of the scaffolds. An independent core laboratory reviewed findings on the first six patients and affirmed that late lumen loss is similar to that observed with bare metal stents. Intravascular ultrasound and optical coherent tomography (OCT) images indicate that the scaffolds are fully opposed to the vessel walls with no indication of recoil or other compromise to their mechanical integrity.
 
"The rapid evolution of this field has been hampered by the inability to develop thin-strut vascular scaffolds displaying stable long-term biomechanical behavior,” said Juan Granada, M.D., executive director and chief scientific officer, Cardiovascular Research Foundation (CRF) Skirball Research Center and primary investigator, Amaranth first-in-human study. “This early human experience confirms both the positive biocompatibility profile of the polymer and biomechanical properties of this device in the absence of drug elution. From our experience to date, we are optimistic that the next generation of the Fortitude technology will permit further miniaturization of the strut but still provide the necessary balance between mechanical strength and bioresorption."
 
For more information: amaranthmedical.com

Related Content

Sponsored Content | Videos | Stents Bioresorbable| March 30, 2017
Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses t
Synergy stent, abluminal polymer DES, bioresorbable polymer DES, bioresorbable polymer metallic stent

The Synergy stent is the first FDA cleared drug-eluting stent to use a bioresorbable polymer drug carrier. When the polymer dissolves after about four months, the devices become a bare metal stent. The technology is supposed to reduce the rate of late stent thrombosis due to vessel inflammation caused by durable polymers.

Feature | Stents Bioresorbable| January 17, 2017 | Dave Fornell
One of the big advancements in drug-eluting stent (DES) technology has been the development of bioresorbable polymers
OCT, intravascular imaging, stent, good stent apposition on vessel wall, TRANSFORM-OCT study

An OCT image showing good stent strut apposition against the vessel wall.

News | Stents| January 13, 2017
January 13, 2017 — Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
Absorb, bioresorbable stent, BVS, top cardiology story of 2016

The FDA clearance of the first fully bioresorbable stent, the Abbott Absorb BVS, was by far the top story of 2016. Readers clearly had a massive interest in this technology based on their page views of this article, related bioresorbable stent content and a video interviews with key ABSORB study investigators.

Feature | December 21, 2016 | Dave Fornell
The Diagnostic and Interventional Cardiology (DAIC) website had a record year in 2016, breaking 1 million pa
Sponsored Content | Videos | Stents Bioresorbable| November 09, 2016
Juan Granada, M.D., executive director and chief scientific officer of the Cardiovascular Research Foundation's Skirb
Biotronik's Osiro stent, prison IV trial

Biotronik's Osiro ultra-thin strut, sirolimus-eluting stent.

News | Stents| November 09, 2016
November 9, 2016 – Results from a randomized, multicenter trial failed to show non-inferiority of hybrid, ultra-thin
OCT stent strut coverage

OCT imaging showing neointimal tissue coverage of metallic stent struts.

News | Stents| November 07, 2016
November 7, 2016 – Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
Fortitude bioresorbable stent

The Fortitude sirolimus-eluting bioresorbable stent.

 

News | Stents Bioresorbable| November 07, 2016
The 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, Oct. 29-Nov. 3 in Washington, D.C...
Svelte Medical Systems, CE Mark, Direct RX, Direct sirolimus-eluting coronary stent rapid exchange system, drug-eluting stent, DES
News | Stents| October 28, 2016
Svelte Medical Systems Inc. announced this week it received CE Mark certification of the Direct Sirolimus-Eluting...
Overlay Init