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.

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/

FDA Approved CardioFocus’ HeartLight® System for Atrial Fibrillation Treatment

CardioFocus, Inc. premarket approval (PMA) from FDA for its HeartLight® Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation (AF).

The device consists of a compliant balloon at the distal end and an optical fiber that can deliver laser energy into the heart. A separate lumen is used to position device that lets the physician visualize the area under the laser gun.

The HeartLight System differs from other AF solutions that rely on x-ray or mapping support for guidance, by allowing the electrophysiologist to control the delivery of therapeutic laser energy, for the first time under direct visual guidance, to electrically and durably isolate the pulmonary veins (PVs).

More info available from Cardio Focus Inc. website.

Innovative interventional resection device approved for CE

The EndoRotor™ System is intended for the removal of alimentary tract mucosa during olonoscopy.

This innovative single resection tool designed for mucosal lesions, which has the potential to replace the need for multiple instruments with 1 and eliminate the time necessary 
for the exchange of multiple instruments.

Interscope, a med tech startup based in USA, declared that their EndoRotor system has obtained CE Mark approval in Europe, however the device is not yet FDA cleared.

The EndoRotor product brochure can be viewed from Interscope website by clicking this link.