Boston Scientific (Natick, Massachusetts) wasn’t wasting time in releasing the next generation of its cardiac resynchronization therapy defibrillator (CRT-D) called Livian, which treats heart failure and helps protect patients at risk of sudden cardiac death. Its subsidiary Gudiant (Indianapolis) earlier developed a similar device called Contak Renewal – which faced a massive recall.

The company reported last week that it had received CE-mark approval for its Livian cardiac resynchronization therapy defibrillator (CRT-D). It is still awaiting FDA approval, however.

“The process has been started - we’ve already filed for FDA and we expect to have Livian on the U.S. market by the first half of 2008,” David Knutson, a spokesman for Boston Scientific’s Cardiac Rhythm Management Division, told Medical Device Daily. “The Livian represents [Boston Scientific’s] first branded CRT-D device.”

The branding is probably the biggest difference between Livian and Contak Renewal. However when you talk about these devices, the differences come from the key features.

He added that “Livian’s special features include an option to monitor heartbeats in heart failure patients and gives doctors a way to manage the patient’s progress. It represents all the work we’ve done.”

The device also delivers small electrical impulses that may improve the heart’s pumping ability.

“Livian is for those patients who are facing heart failure,” Knutson said.

The Livian CRT-D, which is available in high-energy and standard-energy models, enables clinicians to customize therapy based on a patient’s individual needs. The implantable device uses Boston Scientific proprietary technology — built on years of clinical research — and is designed to improve a patient’s response to cardiac resynchronization therapy. The device also offers clinicians technology to help manage heart failure patients with frequent atrial arrhythmias.

Heart failure is a debilitating condition in which the heart weakens and gradually loses the ability to pump blood effectively. Nearly 22 million people worldwide — including about 6.5 million in Europe — currently suffer from heart failure, which affects not only a patient’s quality of life, but also life expectancy. Nearly one million new cases of heart failure are diagnosed annually, making it the most rapidly growing cardiovascular disorder.

“This next-generation CRT-D offers physicians in Europe and elsewhere even more flexibility for tailoring therapy to each patient,” said Jim Tobin, president/CEO of Boston Scientific. “It is a testament to our ongoing commitment to providing innovative solutions for the treatment of heart failure.”

Boston Scientific has been in the business of rebranding previous Guidant devices as of late. Livian follows suit of the company’s Confient ICD, which is a rebranding of Guidant’s Vitality line of devices. Boston Scientific said it received the CE mark for its Confient line nearly two months ago (Medical Device Daily, Oct. 12, 2007).

One overall possible reason for the re-branding could be the company’s need to distance itself from the Gudiant products, which have had numerous recalls and a plethora of lawsuits.

In addition the company has struggled with weak sales since early 2005 on its two key product lines: defibrillators and drug-coated stents. Sales of drug coated stents, metal tubes that are used to prop open arteries, have shriveled amid questions about their safety and benefits.

The company held $8.25 billion in long-term debt as of June 30. Much of the debt is from Boston Scientific’s $27.2 billion acquisition last year of Guidant.

Meanwhile, federal regulators in April lifted a quality-control warning about problems involving a Guidant plant that makes defibrillators and pacemakers — a step that enabled Boston Scientific to resume seeking approval for new devices to correct abnormal heartbeats such as Livian. However, a separate FDA warning involving Boston Scientific’s tracking of safety issues is still pending and is limiting the company’s ability to introduce other types of products.

On top of that the company’s stock has fallen 40% since the Guidant acquisition was announced in early 2006.

But despite a rough go of it in 2007, the company gave a positive prediction for 2008.

“The coming year will be a busy year for us,” Knutson told MDD. “We have eight to 10 products we’re going to be seeking approval for.”