Cardiac Surgery Archives

Medtronic Receives CE Marking for its 31mm CoreValve Percutaneous Aortic Valve

by Gavin Corley on Aug 22, 2011 •

UJFCOW Medtronic Receives CE Marking for its 31mm CoreValve Percutaneous Aortic ValveMedtronic has received CE marking for the latest addition to its CoreValve family of transcatheter aortic valves. The CoreValve System has been designed to provide a minimally invasive treatment option for patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open-heart surgery.

According to the press release, the new 31mm CoreValve system is the largest transcatheter valve available and can be deployed through the same delivery system as smaller CoreValve sizes. Individual valve sizing is essential for achieving ideal patient blood flow and for minimizing the risk of adverse events.

Medtronic’s CoreValve family now includes 26mm, 29mm and 31mm valve sizes – all based on the self-expanding platform that was CE marked in 2007. To date CoreValve System has been implanted in over 15,000 patients in more than 40 countries. The CoreValve System is currently limited to investigational use in the United States.

Press release: Medtronic Gains CE Mark for 31mm CoreValve® Percutaneous Aortic Valve …

Product page: The CoreValve System …

Previous coverage of CoreValve at Medgadget…

Cardiac Surgery

Mitroflow Aortic Pericardial Heart Valve with Phospholipid Reduction Treatment Gets EU OK

by Gene Ostrovsky on Aug 15, 2011
Mitroflow Aortic Pericardial Heart Valve with Phospholipid Reduction Treatment Gets EU OK

Sorin Group received the European CE Mark approval for the Mitroflow Aortic Pericardial Heart Valve with PRT.

The Phospholipid Reduction Treatment (PRT) of the valve is intended to reduce the calcification of the device and hopefully make it durable as the years wear on.

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Anesthesiology / Cardiac Surgery / Critical Care / Diagnostics

Masimo Reintroduces Pronto 7 Finger Sensor After Recall

by Paul Pisklak on Aug 15, 2011
Masimo Reintroduces Pronto 7 Finger Sensor After Recall

We reported on the introduction of Masimo‘s Pronto 7 back in June 2010. To review, this handheld, noninvasive device provides a spot-check of hemoglobin (SpHb), SpO2, pulse rate, and perfusion index.  Since then, Masimo voluntarily recalled the sensors associated with this device due to problems with reliability of data at low ambient temperatures.  The company has subsequently redesigned the sensors and re-validated the data with thousands of patients.

With the new sensors validated, Masimo has initiated international availability of Pronto-7 in Europe, Middle East, Africa, South America, and Asia (except for countries requiring clearance, such as Japan). As far as the U.S. is concerned, FDA 510(k) clearance is pending at this time.

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Cardiac Surgery / Ob/Gyn / Orthopedic Surgery / Plastic Surgery / Surgery / Thoracic Surgery / Urology / Vascular Surgery

SQUAIR Evacuates Surgical Smoke to Reduce OR Aroma of Roasted Human

by Gene Ostrovsky on Aug 12, 2011
SQUAIR Evacuates Surgical Smoke to Reduce OR Aroma of Roasted Human

Via MedCity News we learn of an interesting new device from Nascent Surgical out of Eden Prairie, Minnesota that effectively evacuates almost all the smoke arising from coagulation or use of Bovies and similar electrosurgical devices.

The SQUAIR, as the device is called, is placed around the incision site, with the line of the incision running down the opening of the device.  Once surgery has begun and the vacuum-like unit is hooked up, the SQUAIR sucks up any smoke coming off the patient without any attention given to it by the clinicians.

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Cardiac Surgery / Cardiology / Critical Care

WorldHeart Corporation Ends Its Levacor Ventricular Assist Device Program to Focus on Next-Generation MiFlow VADs

by Ronney Shantouf on Aug 12, 2011
WorldHeart Corporation Ends Its Levacor Ventricular Assist Device Program to Focus on Next-Generation MiFlow VADs

World Heart Corporation (WorldHeart) announced on July 29th, 2011 that it shall no longer pursue commercialization of their Levacor Ventricular Assist Device (VAD) technology and will focus on a smaller, new-generation MiFlow VAD.  WorldHeart’s investor page notes that with continued delay of their Bridge-To-Transplant Study and associated device refinements they no longer see Levacor as a commercially competitive product.  The Levacor VAD, a centrifugal pump that is completely magnetically levitated unlike other assist devices with mechanical or blood-lubricated bearings, is designed for adults with late-stage heart failure as a bridge to transplant.

The company plans to focus on next generation technology such as the MiFlow VAD, a device designed to provide cardiac output flow up to 6L/min.  Its small size is possible secondary to the company’s proprietary Mag-Lev technology.  The MiFlow VAD is also a fully magnetically levitated rotational blood pump.  The company is currently working on a prototype with animal studies expected by mid-2012 and human clinical trials in Europe by 2013.

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Cardiac Surgery / Thoracic Surgery

Elite Bi-Caval Double Lumen Catheter as Bridge Towards Lung Transplantation

by Jan Sinnige on Aug 9, 2011
Elite Bi-Caval Double Lumen Catheter as Bridge Towards Lung Transplantation

Surgeons at the University of Kentucky used a novel dual lumen veno-venous extracorporeal catheter as a bridge to lung transplantation in a patient with a severe pulmonary lung disease. The device was invented by two university faculty members, Dr. Joseph Zwischenberger and Dr. Dongfang Wang.

With current techniques, a patient is sedated while using extracorporeal membrane oxygenation (ECMO). Consequently, the patient is bedridden, which causes the muscles to become increasingly weak. However, the bi-caval double lumen catheter, manufactured by Avalon Laboratories (Rancho Dominguez, CA), is an advanced form of ECMO, also known as “ambulatory artificial lungs.”

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Cardiac Surgery / Cardiology

Medtronic’s Second MRI Compatible Pacing System Gets FDA Approval for a US Clinical Trial

by Ronney Shantouf on Aug 5, 2011
Medtronic’s Second MRI Compatible Pacing System Gets FDA Approval for a US Clinical Trial

The FDA approved Medtronic’s Investigational Device Exemption application and clinical trial protocol to assess the safety and effectiveness of the Advisa DR MRI Surescan pacing system in a clinical MRI setting.  The study will also provide data on how the MRI image quality is affected by the presence of an implanted pacemaker.

The device, as reported prior on Medgadget, has already received European approval in the past. This will be the 2nd MRI compatible system potentially to be available in the US.  The first being Medtronic’s Revo MRI SureScan that received approval last February.

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Cardiac Surgery / Cardiology / Pediatrics

A New Chance on Life: FDA Advisory Panel Recommends Humanitarian Device Exemption for the Berlin Heart Excor Pediatric Ventricular Assist Device

by Ronney Shantouf on Aug 1, 2011
A New Chance on Life: FDA Advisory Panel Recommends Humanitarian Device Exemption for the Berlin Heart Excor Pediatric Ventricular Assist Device

Another big endorsement by the FDA Circulatory System Devices Advisory Panel took place on July 21, 2011. The committee overwhelmingly agreed (16 to 0 vote) that the Berlin Heart Excor Pediatric Ventricular Assist Device (VAD) be granted a humanitarian device exemption (HDE).  The device, as reported prior on Medgadget, provides mechanical circulatory support as a bridge to heart transplantation in pediatric patients suffering from severe isolated left ventricular or biventricular dysfunction.  The sponsors of the VAD presented data from a recent prospective, non-randomized, multi-center, single arm study assessing the safety and probable benefit of the device.  48 children were enrolled in the trial and their outcomes were compared to those receiving ECMO (extracorporeal membrane oxygenation), which is considered the standard of care for bridging children to transplant.  Regardless of a 29% stroke rate, 90% of the children survived to transplant or were successfully weaned off the VAD.  The overall rate of serious adverse events was less in the Excor group versus the ECMO group.  Although the committee wants further investigation of the stroke rates with better-defined outcomes and causes, they do suggest this can be done in the setting of post-approval studies.

The FDA provides HDE for devices that diagnose or treat conditions affecting relatively few people in the US.  The level of evidence needed to obtain HDE is less than regular market application approval.  In general, the device must demonstrate probable benefit and not carry a significant risk for HDE status.

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Cardiac Surgery / Ob/Gyn / Orthopedic Surgery / Surgery / Thoracic Surgery / Urology / Vascular Surgery

MAQUET Releases Yuno OTN Advanced Surgical Table

by Gene Ostrovsky on Jul 21, 2011
MAQUET Releases Yuno OTN Advanced Surgical Table

MAQUET has released a new versatile surgical table that’s future proof, capable of handling patients up to 1,000 pounds.  The unit is mobile and the company believes it can be used in all types of surgeries.

The table features metal-free carbon-fiber structural components for radiotranslucency and easily adjustable components for quick and easy OR prep.

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