News | November 09, 2012

Svelte Medical Systems Announces Approval to Initiate Study of Integrated Delivery System

Svelte Acrobat Bare Metal Stents Svelte Medical Systems Inc

November 9, 2012 — Svelte Medical Systems announced it received conditional approval from the U.S. Food and Drug Administration (FDA) to begin a pivotal study for the Svelte coronary stent integrated delivery system (IDS). Approved by the FDA under an Investigational Device Exemption (IDE), the study will evaluate the safety and effectiveness of the Svelte IDS in approximately 370 patients at up to 30 investigative sites in the United States.

“We are pleased to have earned approval from the FDA to initiate our pivotal study and look forward to collaborating with our clinical partners to demonstrate the clinical, procedural and cost savings benefits of our IDS technology,” said Jack Darby, president and CEO of Svelte. “Given the ever-increasing time constraints and cost pressures confronting cardiac cath labs, we are very confident the Svelte IDS offers an impactful alternative to maximize efficiency while providing best-in-class technology and outcomes.”

The Svelte IDS combines a wire, balloon and stent into a single “all-in-one” system. The low profile and highly flexible IDS navigates through the vasculature similar to a traditional guidewire to allow physicians to direct-stent coronary artery lesions and eliminate several steps from conventional stenting procedures — thereby reducing procedure time and cost. Data presented at medical symposia suggest the Svelte IDS significantly reduces radiation exposure, contrast use, adjunctive interventional product use and overall procedure time when compared with conventional stent systems.

The Svelte IDS utilizing a bare metal stent received CE mark certification in 2010 and is commercially available in select European and Latin American markets. The company completed enrollment in the DIRECT clinical study, a first-in-man evaluation of its drug-eluting stent (DES) utilizing a bioabsorbable drug carrier, and expects to initiate a European-based clinical study in support of CE mark certification of the system later this year. This DES will be offered on both IDS and conventional rapid-exchange platforms incorporating the company’s proprietary balloon control band (BCB) technology upon commercial release.

For more information: www.sveltemedical.com

Related Content

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Overlay Init