News | July 06, 2012

Study Shows Promise for FastSeal Bioabsorbable Vascular Access Closure System

Follow-up results demonstrate superior safety, ease of use, performance, patient comfort and cost effectiveness

July 6, 2012 — Vascular Closure Systems Inc. announced that the 30-day follow-up results for the Phase I first-in-human (FIH) clinicals have been confirmed by Doppler and ultrasound evaluation. The evaluation confirmed normal vessel healing, with complete absorption of the FastSeal sealing element. During the follow-up, no adverse events were observed — no hematoma, pseudoaneurysm or fistulas were present in any of the patients. All patients were asymptomatic and the comfort of the device was excellent, with no groin pain during the deployment, immediately after, at seven and at 30 days after the procedure.

The initial series of human clinical cases were performed by Prof. Alessandro Bortone of the Policlinico di Bari, University of Bari School of Medicine, Italy. Phase II of the FIH clinical tests are currently underway.

The detailed Phase I and Phase II FIH clinical test results will be presented at multiple upcoming medical conferences.

A second manufacturing facility (outside of the United States) has been set up and is producing FastSeal Bioabsorbable Vascular Access Closure systems. Initially, the units being produced are for clinical testing to support regulatory submissions. Once regulatory approval has been granted, the units being produced at this site will be for commercial use.

The company is planning to begin international commercialization (pending regulatory approval) during the fourth quarter of this year.

Vascular Closure Systems is also currently exploring multiple strategic options to enhance shareholder value, including, but not limited to, private funding, a possible strategic alliance, a merger or sale of the company.

For more information: 

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...
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...
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...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
Overlay Init