A Medical Device Daily

Xtent (Menlo Park, California), a developer of next-generation drug-eluting stent systems, said multiple first-ever live coronary technology demonstrations featuring its devices were telecast to last week's Joint Interventional Meeting (JIM) congress in Rome.

Both procedures were performed by Eberhard Grube, MD, via live telecast from the Siegburg Heart Center (Siegburg, Germany).

In an auditorium holding 1,400 interventional cardiologists who collectively represent 54 different countries, the telecast of the first procedure was projected on the first morning of the JIM meeting Feb. 16. The patient's long, diffusely diseased blockage was propped open with a 60 mm long, contiguous coronary drug-eluting stent. This treatment was delivered during a single catheter insertion without gaps or overlapping stents. Noting that standard fixed-length stents typically are 33 mm or shorter, Xtent said that for this patient, multiple deliveries of overlapping stents would have been required.

In the second procedure videocast live to JIM from Siegburg on Feb. 17, a single Xtent catheter was used to deploy two separate stents to cover two separate lesions, each of different length, again without withdrawing the catheter from the coronary vessels. After covering the first lesion, the catheter was repositioned, while remaining inside the coronary arterial system, to a second lesion, where it was used to place a second tailored stent.

Xtent said its system enabled Grube to customize each stent to the size of each lesion treated, while conventional stent deployment practice requires the cardiologist to exit the body entirely and re-enter again with an entirely new catheter system to place each additional stent.

Grube said, “The Xtent system . . . promises to greatly simplify our management of more complex coronary cases.“

Although Xtent's customizable, multi-deployment capability has been used earlier, the company said the JIM videocast offered the first public demonstration of the system's efficacy.

Grube has been the principal investigator for both the Xtent Custom I trial, for which enrollment was completed last July, and the Custom II tria, which began in December. The Custom I trial was designed to demonstrate the Xtent system's capability of customizing stent length to treat single lesions, while the Custom II trial, which included the procedures videocast live to JIM, is designed to apply the Xtent system to longer lesions and more complex, multi-lesion cases.

Greg Casciaro, CEO of privately held Xtent, said, “the strong positive reaction from some of the world's leading cardiologists to Professor Grube's two demonstrations tells us that we are on track to provide a truly disruptive advance in the art of stent placement.“

Janus Flex DES now available

Also at the JIM conference, the Sorin Group (Milan, Italy) said that Janus Flex, its improved new-generation drug-eluting stent, is available in Europe. The authorization for sale is valid for all of the countries in the European Union, where the company said Janus Flex has been fully released.

The tacrolimus-eluting Carbostent system combines a new delivery system with the company's Janus platform. Sorin said the new platform has been designed to offer improved deliverability and conformability in challenging anatomy, as well as providing what it termed “superior flexibility.“

The Janus Flex stent features the Janus stent design, a polymer-free platform with drug reservoir design allowing the drug to be delivered precisely to the vessel wall, along with a new delivery system designed to offer improved deliverability and conformability in challenging anatomy.

The Sorin Group said pre-launch testing performed across Europe has demonstrated the system's superior deliverability vs. other DES systems currently available.

The company said the Janus stent requires no polymer to carry tacrolimus, a cytostatic drug also known as FK506, produced by Astellas, eliminating the shortcomings often associated with polymers.

It said Janus “virtually eliminates“ the risk of thrombosis with its highly bio- and hemo-compatible Carbofilm coating technology.

“We are pleased to release our second-generation drug eluting stent platform one year after the launch of the Janus Carbostent,“ said Stefano Di Lullo , senior vice president, vascular therapy, for Sorin. “[The] Janus Flex delivery system enables physicians to reach more challenging lesions, affording more patients with the opportunity to benefit from this innovative technology.“

Sorin also presented the first six-month clinical results from its e-Janus international “real-world“ registry during the JIM congress, saying they confirm that the Janus Carbostent “provides excellent safety profile and clinical efficacy for the treatment of patients, including the high-risk AMI [acute myocardial infarction] patient population.“

While still recruiting, the e-Janus registry has enrolled more than 2,500 patients at in excess of 80 centers worldwide, excluding the U.S. and Japan.

Six-month clinical follow-up on 587 patients were presented by Dr. J. Koolen of Eindhoven, the Netherlands, the principal investigator of the study.

In the overall population analyzed, Koolen reported a 4.3% major adverse cardiac events (MACE) rate and a 3.1% target lesion revascularization (TLR) rate. MACE includes death, myocardial infarction and TLR.

Of the 587 patients who had completed the six-month follow-up, 31% were diabetic patients, 50.4% were patients with multivessel disease and 23% of patients presented with an AMI. Koolen highlighted the results achieved in the AMI patient subset, with a 3% MACE rate at six-month follow-up. In these 133 AMI patients, the TLR rate was 2.2% and the late stent thrombosis rate for this high-risk subgroup was 0%.

“The initial interim results of the e-Janus study . . . provide further clinical evidence of the benefits of the Janus stent across broad patient groups,“ said Di Lullo.

Redefyne wins CE mark

Anika Therapeutics (Woburn, Massachusetts) said it has received CE-mark approval to market its cosmetic tissue augmentation product, Redefyne, in the European Union. The product is an injectable soft-tissue filler for facial wrinkles, scar remediation and lip augmentation. Redefyne is based on Anika's chemically-modified hyaluronic acid technology and incorporates lidocaine, a local anesthetic.

“Receiving approval to market our cosmetic tissue augmentation product in the European Union is a milestone achievement in our commercialization efforts,“ said Charles Sherwood, PhD, Anika's president and CEO.

He said the company is seeking a partner to commercialize Redefyne worldwide.

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