A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) reported that it has received CE mark approval for the industry's first quadripolar pacing system for cardiac resynchronization therapy defibrillators (CRT-Ds). The quadripolar system offers physicians the ability to more effectively and efficiently manage the ever-changing pacing needs of patients with heart failure. It integrates multiple pacing options and features that enable physicians to better manage common pacing complications without having to surgically reposition the lead.

"Managing heart failure patients is often challenging and typically involves ongoing medical management," said Klaus Gutleben, MD, consultant cardiologist at the Heart and Diabetes Center North Rhine-Westphalia (Bad Oeynhausen, Germany). "This new quadripolar pacing system provides more options for managing the needs of my patients with heart failure and reduces the patient's risk of needing multiple surgical procedures, which should lead to more efficient patient care."

The quadripolar system, with the Quartet left ventricular pacing lead, features four pacing electrodes on the left ventricular lead – enabling up to 10 pacing configurations. Multiple pacing configurations provide physicians with more options to pace around scar tissue in the heart and avoid common pacing complications without the need to surgically reposition the lead.

Common pacing complications that can occur in patients implanted with a CRT system include high pacing thresholds and unintentional phrenic nerve or diaphragmatic stimulation. Patients with high pacing thresholds require significantly higher energy to pace the heart; this may reduce the device's battery life or cause pacing to fail. Phrenic nerve and diaphragmatic stimulation occur when the electrical output from a device inadvertently activates the diaphragm muscle (either directly or via the phrenic nerve), causing hiccups upon each pacing stimulus. Both high pacing thresholds and phrenic nerve or diaphragmatic stimulation are often due to the location of the pacing lead electrode.

"The new features offered in this quadripolar system allow me to mitigate potential complications that would otherwise require an invasive procedure to re-place or reposition the left ventricular lead," said Johannes Sperzel, MD, of the Kerckhoff Klinik (Bad Nauheim, Germany). "Moreover, the lead maintains excellent handling characteristics, as the additional electrodes do not impact my ability to place the lead in the targeted vein."

"CRT has been demonstrated as an important treatment in reducing symptoms and slowing the progression of heart failure. This new system gives physicians more control over patient therapy by providing the flexibility to non-invasively adjust the pacing location or configuration," said Eric Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division. "This approval of the industry's first quadripolar pacing system is demonstrative of St. Jude Medical's commitment to providing physicians with novel technology that addresses clinical needs."

Maquet receives CE approval for MEGA

Maquet Cardiovascular (Fairfield, New Jersey), a provider of cardiovascular technologies, has received the CE mark for its MEGA 8Fr. 50cc intra-aortic balloon (IAB) catheter. As the world's first 50cc IAB with a true 8Fr. shaft, the MEGA has a smaller insertion point than traditional 50cc IABs and offers additional blood volume displacement for intra-aortic balloon counterpulsation, the company said.

MEGA, compared to 40cc IABs, delivers 25% more blood volume displacement and provides improved unloading and augmentation.

Since the MEGA has no step down between the catheter shaft and the balloon material, it may be inserted sheathless or through an 8Fr. sheath. Because of its unique design, it can benefit patients presently using both 50cc and 40cc IABs. The company said that additional benefits include a unique Durathane blow-molded balloon membrane, a full-length polyimide lumen with no gas lumen insert, and numerous safety features such as a Thandle protector to keep the membrane tightly wrapped prior to use.

Intra-aortic balloon counterpulsation is an adjunctive therapy that is often used in patients with left ventricular failure and other cardiac conditions. When the IAB inserted into the patient's aorta counterpulsates with the heart, it augments coronary blood flow to increase myocardial oxygen supply and decrease myocardial oxygen demand.

BioCeramic gets new £1.2M investment

BioCeramic Therapeutics (BCT; London), a developer of novel biomaterials for healthcare, has received £1.2 million of new investment as the company prepares to commercialize its products in 2010.

Imperial Innovations has invested £300,000 and Longbow Capital, a new investor, has invested £400,000. Other investors in the round include Comvest Limited and the Esmee Fairbairn Foundation, both of whom are existing shareholders. In addition, Mark Rowan, a director of Imperial Innovations and a director of, and existing shareholder in, BioCeramic, has invested a further £20,000 in the round. This investment follows funding of £1.04 million in 2007.

BioCeramic has also recently appointed Stephan Rietiker, MD, as its chairman.

BioCeramic is developing bioactive materials for orthopedic and dental applications. Its first products are scheduled for launch in 2010 and include bone graft substitutes that will help treat bone diseases and difficult fractures.

"This cash injection is a huge vote of confidence by our investors on BioCeramic Therapeutic's ability to deliver. It will enable the company to move into its next phase and grow into a commercial, cash generating business," said Rietiker.

BCT is developing two families of implants designed to promote tissue regeneration. Initial applications are in orthopedics and oral care, with plans to extend this to a wide range of other tissues important in human diseases.

Wright moving France operation to Amsterdam

Wright Medical Group (Arlington, Tennessee) has finalized plans to move its distribution and support facilities in France to its European headquarters in Amsterdam, the Netherlands. The company will shut down operations in Crteil, France by Dec. 31.

Wright Medical is anticipating the move will cost the company up to $5 million, including severance and benefits costs to employees displaced by the move. Company officials at Wright's headquarters did not know the number of French employees affected.

Last month, Wright Medical also launched Wright Medical Australia which will manage all of the company's extremity and biologics distribution for customers in Australia and New Zealand.

Wright Medical is a global orthopedic medical device company which develops reconstructive joint devices and biologics.