FDA approves Abbott’s sensor-enabled flexible ablation catheter

Picture: Abbott

Abbott announced U.S. Food and Drug Administration (FDA) approval of the FlexAbility™ Ablation Catheter, Sensor Enabled™ designed to improve the versatility and precision during cardiac ablation procedures to treat atrial flutter, a type of irregular heartbeat. With the approval, the company has further expanded its electrophysiology portfolio for treating patients struggling with abnormal heart rhythms (cardiac arrhythmias).

The FlexAbility™ Ablation Catheter, Sensor Enabled™ is the first ablation catheter from Abbott that helps collect both electrical current resistance (impedance) and magnetic data to facilitate detailed, accurate mapping as well as assist in the treatment of sites that trigger or sustain abnormal heart rhythms. It also represents the second Sensor Enabled™ tool released by Abbott in the United States for the use with the company’s EnSite Precision™ cardiac mapping system, which also includes the Advisor™ FL Circular Mapping Catheter, Sensor Enabled™.

When used with the EnSite Precision™ cardiac mapping system, Sensor Enabled™ catheters allow physicians to create highly detailed 3-D cardiac models with the heart’s electrical activity overlaid on it. These models help the physicians identify the type of arrhythmia and the areas they should treat with the ablation catheter.

The catheter is also compatible with Abbott’s MediGuide™ Technology, which allows the physician to reduce the duration of live X-ray during a procedure.

“I am seeing an increasing number of patients with complex cardiac arrhythmias, which has created a strong need for advanced tools that can meet the needs of those patients” said Jeffrey Winterfield, M.D., director, Ventricular Arrhythmia Service and associate professor of cardiac electrophysiology at the Medical University of South Carolina. “Sensor Enabled™ catheters, along with EnSite Precision™ cardiac mapping system, allow me to quickly identify and treat the arrhythmia, giving me the flexibility and accuracy I need to reach the most challenging locations in the heart to support effective outcomes and improve the lives of my patients.”

The FlexAbility™ Ablation Catheter, Sensor Enabled™ is based on the original FlexAbility™ ablation catheter platform, which featured the first irrigated flexible tip providing directed flow and tip temperature monitoring aimed at reducing procedural risk. The new enhanced FlexAbility™ Ablation Catheter, Sensor Enabled™ adds the ability to collect magnetic data, providing procedural versatility and precision when integrated with Abbott mapping and navigation systems.

“We are continuing to innovate around the EnSite Precision™ cardiac mapping system to create an ablation portfolio that best supports physicians looking to tackle even the toughest cases,” said Srijoy Mahapatra, M.D., medical director of Abbott’s electrophysiology business. “The introduction of the sensor enabled ablation catheter is delivering on that need. It offers the ability to engage the magnetic platform for enhanced precision, especially when physicians encounter a complex case.”

Source: Abbott

FDA approves vessel dilatation device in cardiovascular disease interventions

Serration Technology
Picture: Cagent Vascular, LLC

Cagent Vascular announces FDA 510(k) Clearance of its lead product, the Serranator™ Alto PTA Serration Balloon Catheter.  The Serranator™ is the first of a family of peripheral artery disease (PAD) technologies under development which incorporate proprietary Serration Technology to an angioplasty balloon.

“A new approach to vessel dilatation is long overdue for treatment of diseased peripheral arteries. Today we are treating more complex lesions that require better tools. The Serranator™ is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion,” says Vascular Surgeon Peter Schneider, MD.

“We believe Serration Technology will prove to be effective in more complex lesions and will evolve into the new standard of care for vessel dilatation. In the future we hope to show clinical benefit as a vessel preparation tool with new technologies such as drug coated balloons,” continued Dr. Schneider.

Cagent Vascular has received FDA Clearance for its first product, Serranator™ Alto, indicated for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

“FDA Clearance represents a significant milestone.  Our next step is to initiate a study to assess the clinical safety and efficacy of the technology,” says CEO Carol Burns. “We have also begun the development of the Serranator™ Bass for treatment of the below-the-knee or infrapopliteal arteries, where new technologies are desperately needed for the treatment of Critical Limb Ischemia. Future applications of interest include Serration Technology for vessel preparation prior to the use of Bioresorbable Scaffolds in coronary arteries.”

Source: Cagent Vascular

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St. Jude Launches New PressureWire X Guidewire for Complex Anatomies Patients

St. Jude Medical announced the U.S. clearance and launch of the company’s new PressureWire™ X Guidewire fractional flow reserve (FFR) measurement system. The latest generation of the pioneering PressureWire™ Guidewire system is designed to offer improved shapeability and better shape retention aimed at reducing vessel trauma, with the accuracy and simplicity physicians expect when treating patients during percutaneous coronary intervention (PCI), especially those with complex anatomies.

A PCI procedure, or coronary angioplasty, is a non-surgical procedure designed to open coronary blood flow blockages and restore blood flow to the hearts of patients living with coronary artery disease (CAD)—the most common type of heart disease. PressureWire Guidewire FFR measurements are used by physicians to identify the severity of narrowings in the coronary arteries, which can result in more accurate diagnoses and improved treatment decisions for their patients. Although there are approximately 900,000 PCI procedures performed annually in the United States, only one in five of those are performed using FFR guidance.

“For years, clinical research has confirmed that fractional flow reserve is one of the most important tools available when assessing coronary lesions and making informed treatment decisions during percutaneous coronary intervention,” said Dr. Annapoorna Kini, the director of the cardiac cath lab and the director of the interventional fellowship program at Mount Sinai Medical Center New York, NY. “The improved design and shape retention of the new PressureWire X Guidewire tip allows us to perform FFR measurements in more tortuous anatomies.”

The use of FFR to optimize PCI is supported by strong evidence, and continues to be a topic of multiple clinical studies. In addition to launching the latest PressureWire Guidewire, St. Jude Medical has also launched the PRESSUREwire REGISTRY (Practical Evaluation of Fractional Flow Reserve (FFR) and its Association Alternate Indices During Routine Clinical Procedures), a multicenter clinical trial to determine the routine use of FFR measurement and clinical outcomes of FFR-guided PCI in patients with acute coronary syndrome (ACS), a major cause of global morbidity and mortality.

The PRESSUREwire REGISTRY will build upon clinical trials designed to assess the positive outcomes associated with FFR technology, such as the St. Jude Medical sponsored FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trials, which found that St. Jude Medical PressureWire guidewire technology can improve patient outcomes over angiography alone in patients with CAD.

The St. Jude Medical FAME trial body of evidence also demonstrated reductions in the risk of death or heart attack in patients undergoing PCI, as well as reduced health care costs for patients whose treatment was guided by FFR technology. Primary outcome two-year data from the FAME 2 trial showed that in patients with at least one significant coronary blockage with an FFR value of at least .80, FFR-guided PCI plus medical therapy reduced urgent revascularization by 77 percent compared to medical therapy alone. In 2015, five-year data from the FAME study confirmed the sustained, long-term benefits of FFR-guided PCI over angiography-guided intervention.

FDA Approves Medtronic TrailBlazer Angled Peripheral Support Catheter

Medtronic announced that the U.S. Food and Drug Administration (FDA) has cleared the TrailBlazer(TM) angled support catheter for use in the peripheral vascular system. Support catheters such as the Trailblazer are often used in endovascular procedures treating complex peripheral artery disease (PAD).

The new TrailBlazer angled support catheter is designed to support a guide wire during access to the peripheral arteries, and to enable delivery of solutions and diagnostic agents. The catheter features a braided stainless steel shaft for robust pushability and a 25 and 30 degree angled tapered tip to access and cross complex lesions. To enhance physician visibility, each of the .014″, .018″ and .035″ guidewire compatible devices is designed with three radiopaque marker bands and a radiopaque shaft. Additionally, both the .014″ and .018″ TrailBlazer angled support catheter can fit coaxially through the .035″ support catheter for increased reach and pushability.

A press release can be found from Medtronic Website.

Bluegrass Vascular Receives CE for The Access Catheter System

Bluegrass Vascular announced that it has received CE Mark approval and is launching limited commercial sale of its Surfacer® Inside-Out® Access Catheter System. The Surfacer System is indicated for obtaining central venous access to facilitate catheter insertion into the central venous system via a novel Inside-Out approach.

A press release can be found from Bluegrass Vascular website.

New sheath provides exceptional access to challenging anatomies and branch vessels

W. L. Gore & Associates, Inc. announced the commercial availability of the GORE® DrySeal Flex Introducer Sheath, after recently gaining clearance for use by regulatory bodies in the U.S., Europe, Canada, and Australia. The device is designed with a distinct combination of enhanced flexibility, kink resistance, and a hydrophilic coating to facilitate access to challenging anatomies and branch vessels, such as the common iliac arteries, during endovascular repair procedures.

The 12 Fr x 45 cm sheath configuration is engineered specifically for use with the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), the only device indicated in the U.S. for endovascular repair (EVAR) of common iliac artery aneurysms or aortoiliac aneurysms. An EVAR often requires multiple wires and catheters be transferred into the vessel via an introducer sheath, which can lead to blood loss through the sheath valve. The sheath’s exclusive DrySeal valve was designed to minimize blood loss, enabling the introduction of multiple devices with proven hemostasis control.

“Nearly a third of patients being considered for EVAR have an aneurysm that extends to the iliac artery. The IBE is a trusted solution in such cases, but previously no introducer sheaths designed for use with this device existed,” said Mr. Marcus Brooks, Consultant Vascular Surgeon, North Bristol NHS Trust. “With the GORE DrySeal Flex Introducer Sheath, I now have a sheath specifically designed for use with the IBE and flexible enough for easy access to the iliac branch vessels.”

The new sheath leverages technology from Gore’s long-trusted GORE® DrySeal Sheath, which features a hydrophilic coating for improved access into vessels. In addition, the GORE DrySeal Flex Introducer Sheath offers an optimized profile and new configurations which include working lengths of 33, 45, and 65 cm.

“The availability of this new sheath provides more options to treat a broader range of patient anatomy,” said Jason T. Lee, MD, Professor of Surgery at Stanford School of Medicine. “The sheath supports my cases from start to finish, offering confidence for a wider range of applications than ever before.”

“By linking our tested GORE DrySeal Flex Introducer Sheath with our endovascular portfolio, we continue to make great strides in advancing patient care,” said Ryan Takeuchi, Gore Aortic Business Leader. “We remain committed to making these innovative devices available to treat more patients globally.”

The GORE DrySeal Flex Introducer Sheath and IBE are available in the U.S., Europe, Canada, and Australia. For more information please visit http://www.goremedical.com/