News | Peripheral Artery Disease (PAD) | February 15, 2017

Clinical Trial Data Presented from Mercator MedSystems’ DANCE Trial at ISET and LINC

First large-scale trial of Bullfrog Micro-Infusion Device with dexamethasone shows positive results

Mercator MedSystems, DANCE trial data, ISET, LINC, Bullfrog Micro-Infusion Device

February 15, 2017 — Mercator MedSystems announced that the national co-principal investigators of the company’s DANCE trial each presented comprehensive 13-month trial data during Late-Breaking sessions at ISET (International Symposium on Endovascular Therapy) in Hollywood, Fla., and LINC (Leipzig Interventional Course) in Leipzig, Germany.

The ISET data was presented by Mahmood Razavi, M.D., and the LINC data was presented by George Adams, M.D.

Mercator MedSystems’ Bullfrog Micro-Infusion Device was used in the trial to deliver a generic anti-inflammatory steroid (dexamethasone) along with radio-opaque contrast to visualize distribution. The drug was delivered to the tissues around femoropopliteal arteries after undergoing endovascular intervention to forcibly open obstructions. The data demonstrate a high level of durability of the revascularization, low occurrence of major adverse limb events, and no device or drug-related adverse events.

“We attribute the success seen in the DANCE trial to the Bullfrog device and its ability to efficiently deliver drug in difficult-to-reach anatomy,” said Razavi. “Technologies such as drug-coated balloons or drug-eluting stents use chemotherapeutic agents to reduce the risk of scar tissue buildup inside the arteries. Alternatively, we have proposed that the delivery of an anti-inflammatory agent to the outside of the artery enhances the healing process and interrupts the cascade leading to scar formation and restenosis. Overall, we have found the therapy in DANCE to be intuitive, safe and effective.”

The 13-month data from DANCE were separated into two groups based on method of revascularization: Atherectomy was performed in 157 limbs, while 124 limbs received angioplasty without atherectomy. For both groups, the primary safety endpoint revealed no post-operative death within 30 days, with major adverse limb events prior to a revascularization reported as 1.6 percent in the atherectomy group and 0.9 percent in the angioplasty group. The per-protocol primary efficacy endpoint of primary patency did not widely vary between groups, with 83.6 percent at 12 months and 80 percent at 13 months in the atherectomy group, and 80.2 percent at 12 months and 78.2 percent at 13 months in the angioplasty group. Primary patency was defined as the lack of clinically-driven target lesion revascularization (CD-TLR) or narrowing detected by a duplex ultrasound peak systolic velocity ratio (PSVR) greater than 2.4. Freedom from CD-TLR was 89.6 percent at 12 months and 88.7 percent at 13 months in the atherectomy group, and was 89.1 percent at both 12 and 13 months in the angioplasty group. No broad disparities were reported among results by gender, with 13-month primary patency of 79.3 percent in men and 77.9 percent in women, or by diabetic status, with 13-month primary patency of 79.5 percent in diabetics vs. 78.8 percent in non-diabetics.

The Mercator Bullfrog Micro-Infusion Device is a U.S. Food and Drug Administration (FDA) 510(k)-cleared and CE-Marked system designed to infuse therapeutic and diagnostic agents directly, non-systemically and safely through blood vessel walls into adventitial tissues. The device is tipped with a balloon-sheathed microneedle, and is compatible with 0.014-inch guide wires and 5 to 7 French introducer sheaths. The closed balloon provides a protective covering for a tiny, perpendicular-oriented injection needle as it is guided safely through the vasculature to target vessels with diameters of 2 to 8 millimeters.

For more information: www.mercatormed.com

Related Content

CardiAMP Heart Failure Trial Design Presented at Texas Heart Institute Symposium
News | Heart Failure| September 25, 2017
BioCardia Inc. announced the trial design for its pivotal Phase III CardiAMP Heart Failure Trial was presented during...
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.
Lesion Preparation Via Atherectomy Enhances Paclitaxel Distribution in Calcified Peripheral Arteries
News | Peripheral Artery Disease (PAD)| September 20, 2017
September 20, 2017 — Not-for-profit preclinical research institute CBSET announced that its scientists have published
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...
Overlay Init