Svelte™ Medical Systems, Inc. has announced that it has officially received the CE Mark to market its Acrobat  Stent-on-a-Wire (SOAW) Bare Metal Coronary Stent System in the European Union. The Acrobat  SOAW stenting system has been shown in clinical trials to facilitate direct stenting and has the potential to provide substantial procedural time and cost savings. These savings are realized by eliminating the need for a coronary guidewire and balloon dilatation catheters.

Read full story here

Boston Scientific Corporation has announced the start of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of its fourth-generation SYNERGY™ Coronary Stent. The SYNERGY Stent uses a bioabsorbable PLGA polymer and everolimus drug formulation to create a thin, uniform coating confined to the outer surface of the stent. Once the drug has been delivered, the bioabsorbable coating resorbs into the body, leaving behind only a bare-metal stent.

Read the full story here

Medtronic Inc.’s Physio-Control subsidiary said that it has launched a field correction effort to fix certain devices used to shock patients in cardiac arrest because it found a potential battery-power problem, and that one patient may have died as a result. The FDA said nearly 43,000 Lifepak 20 and Lifepak 20e defibrillator/monitors are at issue worldwide.

Read the full story here.

The Food & Drug Administration has slapped Medtronic Inc’s subsidiary Physio-Control Inc. with a Class I recall of its LifePak 20/20e defibrillators after the company declared a “field correction” for a battery problem last week. Physio-Control issued a “field correction” on July 2, after discovering that some of the devices might lose battery power while in operation.

Endologix Inc said that the Food and Drug Administration has approved the expansion of its main product line. The FDA approval covers 31 new sizes of its Powerlink stents, which it said should expand the number of patients they can be used on by to 5% to 10%. Endologix’s stents are used to reinforce a ruptured or ballooning section of an artery.

Pacemaker manufacturer St. Jude Medical Inc. and two hospitals have agreed to pay nearly $4 million to resolve fraud allegations, the Justice Department announced Friday. The Justice Department had accused St. Jude of paying kickbacks to hospitals in Ohio and Kentucky to secure heart-device business. St. Jude is to pay $3.7 million and the hospitals to pay a combined $173,000 to resolve the allegations.

A new pacemaker that makes it safe for heart disease patients to have a vital diagnostic test they previously could not has been implanted in the first Tasmanian. Previously Tasmanians with pacemakers in their hearts could not undergo Magnetic Resonance Imaging (MRI) scans used to detect cancer, strokes and other disease. Hobart cardiologist Leigh Bowman says the new MRI-friendly pacemaker will make a big difference as at least half of pacemaker patients will need an MRI in their lifetime.

A middle-school teacher was revived after collapsing when a police officer at a Bellevue school on another call helped deploy a defibrillator. As part of a pilot program to improve heart attack survival rates, Bellevue and Kent police officers were issued portable automatic electronic defibrillators and trained in their use in March.

The maker of a battery pack used in automated external defibrillators (AEDs) voluntarily recalled more than 5,000 of its units due to potentially fatal errors it causes in devices charged with the battery. The FDA has labeled the recall class I, reflecting the most severe warning and meaning that the affected device has a high probability of causing serious adverse events or death with use.

Endologix Inc, a medical device maker, said it has received approval from the US regulatory authority to market an expanded offering of its Powerlink stent graft products. Powerlink, which is an already approved endovascular stent graft, is used in the treatment of abdominal aortic aneurysm. In abdominal aortic aneurysm, the aortic wall weakens, creating a “ballooning” of the blood vessel.