Cardiac Surgery Archives

New SJM Optisure Defibrillation Lead Has Extra Insulation

Optisure Lead New SJM Optisure Defibrillation Lead Has Extra Insulation

St. Jude Medical, having received approval in U.S., Europe, and other markets, is releasing its new high-voltage Optisure defibrillation lead. The device is based on the company’s Durata lead, but with extra insulation at the proximal end of the lead.

It’s compatible with all St. Jude Medical implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D).

More about the new lead from the announcement:

Based on the established Durata lead design, the Optisure lead features additional Optim insulation at the proximal end of the lead, including under the superior vena cava (SVC) shock coil. The lead design is identical to Durata distal to the SVC shock coil. Optim insulation is a hybrid insulation material unique toSt. Jude Medical and created specifically for cardiac leads. It blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane to provide increased durability, along with the flexibility and handling characteristics that facilitate device implantation. With both 7 and 8 French diameter leads, the St. Jude Medical high-voltage portfolio now provides physicians more treatment options to tailor therapy to individualized patient needs.

The Optisure defibrillation lead is compatible with all of the company’s implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), including the company’s next-generation Ellipse™ and SJM Assura™ portfolio of ICDs and CRT-Ds.

Product page: Optisure Defibrillation Lead…

Press release: St. Jude Medical Announces Global Launch of Optisure Defibrillation Lead…

Three New Pacemakers from SJM, Including a Quadripolar, Approved in U.S.

Three New Pacemakers from SJM, Including a Quadripolar, Approved in U.S.

St. Jude Medical received FDA approval for its Allure Quadra cardiac resynchronization therapy pacemaker (CRT-P), as well as for the Assurity and Endurity pacemakers. The Allure Quadra is the first pacemaker approved in the U.S. that provides quadripolar pacing capabilities via the four electrodes on the leads that extend to the heart. Traditional pacemakers are bipolar, limiting the options that the cardiologist has in terms of signal pathways through the myocardium. Because it can be adjusted more effectively after implantation, quadripolar technology can help prevent unnecessary lead repositioning procedures.

The Assurity and Endurity are more tradtiional pacemakers, available in single or dual chamber varieties. All of the newly available devices interface with St. Jude Medical’s Merlin.net online reporting system that keeps transmits device data to the patient’s physician for review.

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

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

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.

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

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

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.

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Toshiba’s CT Myocardial Perfusion Imaging Technology FDA Cleared

Toshiba's CT Myocardial Perfusion Imaging Technology FDA Cleared

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.

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

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

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.

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Perminova Aims to Monitor Chest Fluid for Early Detection of Heart Failure and Other Diseases

Perminova Aims to Monitor Chest Fluid for Early Detection of Heart Failure and Other Diseases

Being able to detect the escalating pleural effusions in patients with congestive heart failure (CHF), cancer, and other conditions could prevent clinical deteriorations, avoid mortalities, and improve health care costs. Typically, pleural effusion is diagnosed with a chest X-ray, but that usually happens when patients seek medical care for already developed symptoms.

The CoVa necklace from Perminova, a company out of La Jolla, California, is a new tool being developed to measure chest fluid levels regularly and conveniently. Electrodes on the bottom of the necklace are firmly attached to the chest using an adhesive and the device is worn for about fifteen minutes a day while measurements are done and recorded. Beside thoracic fluid measurement, the CoVa necklace also records the heart rate, respiration rate, heart rate variability, stroke volume, cardiac output, single-lead ECG, and posture, according to MobiHealthNews. The company is now planning to apply for an FDA clearance for the device and introduce it to hospitals in the U.S.

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Mardil VenTouch Heart Pressure Wrap Being Studied in First Patients (VIDEO)

Mardil VenTouch Heart Pressure Wrap Being Studied in First Patients (VIDEO)

Functional mitral regurgitation has a number of treatment options – each with its benefits, limitations, and side effects. Prosthetic valves and open heart surgery are common, but an ambitious new option that might be appropriate for a lot of patients is now being tested for the first time in humans. The VenTouch system from Mardil Medical (Plymouth, MN) wraps the heart in an implantable pouch that delivers pressure onto the enlarged left ventricle and hopefully helps improve cardiac function.

It’s delivered through an incision between the ribs and doesn’t require any actual surgery to the heart, mitral valve, or vasculature around them. The device can be deflated or inflated to adjust its effectiveness post surgery using a syringe via a port on its side. The first two patients had the implant installed at the National Heart Institute in Kuala Lumpur, Malaysia and others are to follow in other institutions around the world. Here’s a video explaining the implantation of the VenTouch:

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Edwards SAPIEN XT Approved in Europe for Valve-in-Valve Aortic, Mitral Procedures

Edwards SAPIEN XT Approved in Europe for Valve-in-Valve Aortic, Mitral Procedures

Prosthetic heart valves, due to the continuous stress they’re subjected to, have a limited lifetime and may even require replacement once worn out. The problem is that after implantation the patients who wear these valves don’t get any younger, but often sicker, and a redo surgery to replace the valve can be mortally risky.

Edwards Lifesciences just received European CE Mark approval to offer the SAPIEN XT transcatheter valve for valve-in-valve procedures. The SAPIEN XT is indicated for implantation inside both mitral and aortic valves, and can reside on top of a previously installed prosthetic valve.

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