Vascular Surgery Archives

Abbott Supera Stent for Peripheral Artery Disease Stays Flexible for a Comfy Fit (VIDEO)

by Editors on Mar 28, 2014

Abbott Supera stent Abbott Supera Stent for Peripheral Artery Disease Stays Flexible for a Comfy Fit (VIDEO)

Abbott received FDA approval for its Supera Peripheral Stent System for treating occluded superficial femoral and proximal popliteal arteries of the legs. The nitinol stent was developed to “mimic rather than resist” the movement of the arteries, being flexible while keeping the lumen open during physical activity and resisting kinks.

Here’s more from the announcement:

“Doctors are increasingly identifying peripheral artery disease as a major cause of leg pain, which can limit people’s ability to live a healthy lifestyle,” said Kenneth Rosenfield, M.D., section head of Vascular Medicine and Intervention at Massachusetts General Hospital and the principal investigator of the SUPERB clinical trial, which evaluated the Supera stent. “Treatment with the Supera stent, as shown by the results of the SUPERB study, is very effective in easing leg pain, enabling the majority of patients to resume their activities.”

Data from the SUPERB clinical trial, which was used to support FDA approval of the Supera stent, have shown the Supera stent to be highly effective in opening up blocked blood vessels in the upper leg, even in difficult cases, and results have been shown to last over time.² In addition, during the first year after treatment with the Supera stent there were no stent fractures, and at two years there was a very low stent fracture rate of 0.5 percent.² Stent fractures are a known risk of treatment with traditional metallic stents in the leg due to the frequency and type of movement in this part of the body.

Press release: Abbott Announces FDA Approval of Its Supera® Stent to Treat People with Peripheral Artery Disease…

Telelap ALF-X Endoscopic Robotic Surgical System

by Editors on Mar 21, 2014

Intuitive Surgical is the dominant player in robotic surgery, having developed the now famous da Vinci System that turned traditional endoscopy into a futuristic endeavor. Now we learn of a system being developed by SOFAR, an Italian pharmaceutical firm, that looks set to compete with the da Vinci.

The Telelap ALF-X features haptic feedback, allowing the surgeon to indirectly “feel” the tissues that are being manipulated. This can lead to improved safety and allow certain maneuvers to be performed with greater confidence. The system also tracks the surgeon’s eye movements, positioning the camera so the field of view is centered where the eyes are looking. The system is highly adjustable for an optimal ergonomic experience. Here are a few video previews of the system in action:

Medrobotics’ New Flex System for Snake-Like Surgical Endoscopy Cleared in Europe

by Editors on Mar 20, 2014

Surgical endoscopy has been hailed as the route to an end to open surgical procedures, but many relatively simple operations still have to be done with a scalpel. Enter the Flex System from Medrobotics (Raynham, Massachusetts), the first surgical endoscopy device with snake-like abilities that allow it to reach places that straight instruments simply can’t.

The technology behind the Flex was originally developed at the Carnegie Mellon Robotics Lab and developed further by Farm, a medical device product development firm. It involves flexible concentric components that can be made to be stiff or go limp as necessary, together acting like a snake that can be positioned around obstacles. The tip of the snake can accept a variety of instruments through the multiple channels within the endoscope, and also hosts a forward looking high definition video camera.

Evoked Potential Assessment Device Prevents Arms and Legs from Falling Asleep During Surgery

by Editors on Mar 19, 2014

All of us have fallen asleep on an arm or sat too long on a twisted leg only to get up and feel like the limb itself has fallen asleep. Nerves can get stretched and compressed, and blood vessels squeezed, and, if a person’s position is not corrected soon enough, it can lead to permanent tissue damage, compartment syndrome and such . This scenario can happen during surgery, but since the patient is anesthetized and can’t feel, the situation usually goes undetected and can lead to significant damage. A new product from SafeOp, a company out of Hunt Valley, Maryland has received FDA clearance for “positioning effect” monitoring without having a dedicated nneurophysiological monitoring team.

The Evoked Potential Assessment Device (EPAD) uses SSEPs (somatosensory evoked potentials) to detect abnormal nerve signaling that is indicative of poor patient positioning. The output of the device is sent wirelessly via Bluetooth to a tablet that can be hung beside the patient to allow a live view of the positioning effect so that clinicians can move the patient and prevent intra-op damage.

Toshiba’s CT Myocardial Perfusion Imaging Technology FDA Cleared

by Editors on Mar 14, 2014

Toshiba received FDA clearance to introduce its CT Myocardial Perfusion technology, now being made available on the company’s flagship CT scanners, the Aquilion ONE and Aquilion ONE ViSION Edition.

CT Myocardial Perfusion allows the diagnosis of myocardial ischemia by visualizing the flow of blood within the coronary vasculature. Toshiba will be showing off the new package on its 320-detector-row CT scanners at the American College of Cardiology (ACC) annual meeting in Washington, D.C. later this month.

CareFusion’s V. Mueller New Line of Bipolar Electrosurgical Tools

by Editors on Mar 11, 2014

CareFusion is releasing a new line of customized bipolar electrosurgical devices that include a variety of forceps and scissors. The V. Mueller branded tools can be selected by surgeons to be non-stick, be made of titanium, and have irrigation capabilities.

The bipolar energy delivery to the instrument through a single cord allows for less damage to nearby tissue while preventing cords from tangling around each other and allowing surgeons easier access around the surgical site.

Medicine / Radiology / Vascular Surgery

Cordis RENLANE Renal Denervation Cleared in Europe

by Editors on Feb 25, 2014

Cordis, a unit of J&J, received European CE Mark approval for its RENLANE renal denervation system for treatment of blood pressure in patients for whom traditional therapy is not effective. The catheter is powered by an external multi-channel RF generator and features five irrigated electrodes through which energy is delivered to denervate renal arteries that are participants in controlling blood pressure.

The company already announced initial procedures using the device at the University of Cologne Hospital in Germany to treat patients with a systolic blood pressure over 160 mm Hg. The patients were discharged after a day at the hospital and we’re very curious, considering Medtronic’s recent failure with their own renal denervation system, to see what the long term impact of this therapy is on patients.

World’s Smallest JustRight 5mm Surgical Stapler FDA Cleared

by Editors on Feb 19, 2014

JustRight Surgical, a company out of Boulder, Colorado, won FDA 510(k) clearance from the FDA for its JustRight 5mm surgical stapler, making it the smallest classic stapler on the market. Developed for pediatric surgeries, it can also be practical in adult surgeries when a small instrument can provide improved access while maintaining visibility.

Here’s a feature list from the product page:

Medtronic TOTAL Across Crossing Catheter Approved in EU

by Editors on Feb 14, 2014

Medtronic, having received European regulatory approval, is launching its TOTAL Across crossing catheter on the continent. The device is designed to help deliver guidewires 0.014-inch in size to the arteries in the legs, including below the knee (BTK), to cross occlusions that would otherwise be inaccessible with larger catheters. Guidewires can be swapped out as necessary, and saline or contrast agents can be pumped in through the catheter.

The device is made out of stainless steel wrapped into a flexible helix, with a tapered tip up front that can penetrate lesions narrower than the device’s cross-sectional diameter.