Promus Element Plus BTK DES

Company Boston Scientific Corporation
Phone (888) 272-1001
Web www.bostonscientific.com
Key Features

  • Balloon-expandable drug-eluting stent for critical limb ischemia and and severe claudicant patients
  • New platinum-chromium alloy and stent design
  • Platinum-chromium specifically developed for improved radial strength, visibility and deliverability
  • 2.25–4-mm diameters, 12–38-mm lengths
  • Monorail and over-the-wire on 0.014-inch wire platform

The Promus Element Plus BTK (below-the-knee) drug-eluting stent (Boston Scientific Corporation, Natick, MA), which recently received CE Mark approval, uses a proprietary platinum-chromium alloy designed specifically for stenting, enabling enhanced visibility and much higher radial strength and resistance to compression compared to older cobalt-chromium stents. The everolimus drug and fluorinated copolymer stent coating have been studied in multiple randomized coronary clinical trials and real-world registries, demonstrating exceptional long-term safety and efficacy, according to Boston Scientific Corporation.

The Promus Element Plus BTK is indicated for the treatment of critical limb ischemia or severe lower leg claudication in infrapopliteal lesions. The device has CE Mark approval for both monorail and over-the-wire versions.

“The drug-eluting stent is an important additional tool that I use to address focal stenosis in the arteries below the knee and ultimately reduce amputation rates in CLI and claudicant patients,” commented Martin Kamarád, MD, in the company's press release. Dr. Kamarád is associated with the Podlesí Hospital in Trinec, Czech Republic. He continued, “In addition to the benefits of drug delivery, I believe the Promus Element Plus BTK stent offers significant advantages in terms of properties in the design and higher resistance to compression and less recoil, thanks to its unique platinum-chromium alloy and stent architecture.”

Acandis Aperio 1.9-F Thrombectomy System

Company Acandis GmbH & Co. KG
Phone 0049 7231 155000
Web www.acandis.com
Key Features

  • Balloon-expandable drug-eluting stent for critical limb ischemia and and severe claudicant patients
  • New platinum-chromium alloy and stent design
  • Platinum-chromium specifically developed for improved radial strength, visibility and deliverability
  • 2.25–4-mm diameters, 12–38-mm lengths
  • Monorail and over-the-wire on 0.014-inch wire platform

Acandis GmbH & Co. KG (Pforzheim, Germany), announced CE Mark approval of the Acandis Aperio 1.9-F thrombectomy system. The company plans to launch the product in Germany and other CE Mark countries during the fourth quarter of 2012.

With sizes compatible with vessel diameters of 2 to 4 mm, the Acandis Aperio 1.9-F thrombectomy system is suitable for use in all of the cerebral main vessels, as well as those that are more distal and more difficult to reach. The reduced-profile design increases the lumen available for aspiration through the guiding catheter. The system also includes radiopaque transport wire markers and three low-profile gold markers at the distal device end for visualization support and accurate positioning. The unique hybrid cell design of the laser-cut nitinol device catches the clot effectively, supporting reliable clot removal and rapid flow restoration. The Aperio 1.9-F thrombectomy system can be used up to three times based on the severity of the clot, stated Acandis.

R-Band Radial Hemostasis Device

Company Vascular Solutions, Inc.
Phone (763) 656-4300
Web www.vasc.com
Key Features

  • Compression band targets hemostasis needs in rapidly growing radial artery access for performing cardiology procedures
  • Device comprises soft plastic wrist strap with adjustable hook and loop fasteners, two inflatable compression balloons, and inflation syringe
  • Clear plastic strap and compression balloons allow clinician to visualize access site

Vascular Solutions, Inc. (Minneapolis, MN) announced the launch of the R-Band radial hemostasis compression device in the United States. The R-Band, which has received 510(k) clearance, is a radial compression device that is used by interventional cardiologists to achieve hemostasis following transradial diagnostic and interventional catheterization procedures. The device consists of a soft plastic wrist strap with adjustable hook and loop fasteners, two inflatable compression balloons, and an inflation syringe with a proprietary connector tip. After applying the strap around the patient's wrist, the physician inflates the compression balloons to apply gentle pressure to the puncture site of the radial artery, while maintaining flow through the ulnar artery. The clear plastic strap and clear compression balloons allow the clinician to visualize the access site during the entire process.

“Radial access is undergoing tremendous expansion in the US, and we are especially pleased that the addition of the R-Band will allow us to offer a broader range of products for radial hemostasis to fit physician preferences, supplementing our existing Rad-Band and D-Stat Rad- Band products,” said Howard Root, Chief Executive Officer of Vascular Solutions. “In addition, the R-Band provides obvious synergies with the Accumed wrist positioning splint that we acquired in June.”

Victory Guidewire

Company Boston Scientific Corporation
Phone (763) 494-2012
Web www.bostonscientific.com
Key Features

  • Four gram-load options ranging from 12 to 30 g
  • Unique stainless steel core technology
  • Hydrophilic coating that provides enhanced lubricity

Boston Scientific Corporation (Natick, MA) announced the launch of its Victory guidewire in the United States and Europe. The company expects to launch the product in other international markets later this year and in 2013, subject to regulatory approvals.

According to Boston Scientific, the Victory guidewire is designed to facilitate crossing of resistant lesions and the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature. The device is available in a broad matrix of high gram-load tip options ranging from 12 to 30 g. The Victory guidewire is offered in both 0.014-inch and 0.018-inch diameters, and with four different gram-load options, it offers clinical versatility and a range of pushability. Stainless steel core technology enables the wire to have superior torque for optimal steering and control. Furthermore, a hydrophilic coating provides enhanced lubricity to facilitate crossing resistant lesions, the company stated.

Pinnacle Precision Access System

Company Terumo
Phone (800) 862-4143
Web www.terumois.com
Key Features

  • Tapered introducer needle dilates tissue, minimizes vessel trauma
  • Precise access for cases that are impeded by scar tissue or calcification
  • Eliminates need for a micropuncture kit and standard-size introducer sheath

Terumo Interventional Systems (Somerset, NJ) recently announced the nationwide availability of its new Pinnacle Precision Access System, a state-of-the-art vascular access system specifically designed for smooth, efficient, and reliable vascular access. The Pinnacle Precision Access System offers the only available tapered introducer needle designed to help minimize vessel trauma, dilate the tissue, and gain more precise access in difficult cases, such as those impeded by scar tissue or calcification.

“Terumo's Pinnacle Precision Access System is one of the most innovative advancements in technology that will help us achieve success in peripheral vascular intervention, specifically where critical limb ischemia is present,” said Jihad Mustapha, MD, FACC, FSCAI, Director of Endovascular Laboratories and Director of Cardiovascular Research, Metro Heart & Vascular, Metro Health Hospital, in Wyoming, Michigan. “From the tapered needle to the Total Integrated Fit sheath, Terumo provides a seamless transition for vascular access femorally or peripherally.”

One of the Pinnacle Precision Access System's most significant advantages is the elimination of procedural steps compared to alternative products. Terumo's new Pinnacle Precision Access System eliminates the need for both a micropuncture kit and a standard size introducer sheath. It features proven Total Integrated Fit technology and a new tapered 21-gauge needle that allow for a smaller, straighter, and more accurate puncture to help reduce vessel entry site trauma and access complications.

Visions PV .035 Digital IVUS Catheter

Company Volcano Corporation
Phone (800) 228-4728
Web www.volcanocorp.com
Key Features

  • 60-mm imaging diameter to support your large vessel and 0.035-inch applications
  • New radiopaque and inked centimeter markers
  • Longer PIM connector length (compared to previous model)

The Visions PV .035 digital IVUS catheter (Volcano Corporation, San Diego, CA) is Volcano's newest intravascular ultrasound offering for large vessels or applications using an 0.035-inch guidewire. Like the previous Visions PV 8.2-F model, the catheter generates a large 60-mm imaging diameter to enable a full view of large vessels even when the wire is biased to one side. New features include two types of centimeter markers along the entire working length and an extended connector cable length. New centimeter markers, radiopaque on the distal portion of the catheter and inked on the proximal end, facilitate length measurements and may save the step of a separate marker catheter exchange. The longer connector length increases slack to improve procedural flexibility compared to the previous model. The catheter also incorporates a hydrophilic coating and is labeled for 8.5-F sheath compatibility.