Medical Device Daily Contributing Writer And MDDs

WASHINGTON — Onyx from ev3 (Plymouth, Minnesota) is an important product for this company, according to its presentation to analysts at last week's Transcatheter Cardiovascular Therapeutics conference.

The company said that Onyx, an embolic agent — primarily used to treat arterial-venous malformations (AVMs) in the brain — has been a key contributor to the company's growth over the past several quarters.

Although a relatively small market compared to intranial aneurysms, an AVM is a severe condition that can lead to stroke and death, if untreated. Since entering the U.S. market in the summer of 2005, ev3 has been successful in wresting market share from Cordis (Miami Lakes, Florida), which sells a "super-glue"-like product called Trufill.

Matthew Jenusaitis, an ev3 division president, said he believes that the company has already garnered 50% of the dollar share of this market.

Jenusaitis reported that ev3 has filed a Humanitarian Device Exemption with the FDA for Onyx for use in larger aneurysms that are not treatable with conventional coils. The timing of agency approval for this use is not certain, according to the company.

Gary Duckwiler, MD, a prominent interventional neuroradiologist from University of California Los Angeles (Los Angeles), says that Onyx has several advantages relative to Trufill, including ease of use, better penetration time and greater safety due to its longer working time.

Duckwiler, who participated in the analyst meeting, was enthused about other potential uses for Onyx in different areas of the body, including peripheral AVMs and for repairing endograft leaks.

The other initiative high on ev3's radar screen in the INR market is the launch of improved coils, which are now in development and could be introduced later in 2007. ev3 is a relative small player in the intracranial aneurysm market and needs improved technology to gain market share from the other companies.

"We are still a small company, with plenty of room to grow," said Jenusaitis.

In another report from TCT:

Early clinical results from the ongoing ABSORB clinical trial, the world's first study to evaluate the safety and performance of a fully bioabsorbable drug-eluting stent platform — XIENCE V Everolimus Eluting Coronary Stent System — developed by Abbott (Abbott Park, Illinois) for the treatment of coronary artery disease in humans, were presented at a scientific symposium.

Initial results for the first 30 patients in the trial demonstrated no major adverse cardiac events and no stent thrombosis at 30 days for patients who received the bioabsorbable DES.

The DES device is made of polylactic acid, designed to be fully absorbed and slowly metabolized by the coronary artery. The stent releases everolimus into the artery and then is slowly absorbed over time. The goal is to leave a healed natural vessel behind.

"We are highly encouraged by these initial results from the ABSORB trial," said John Ormiston, MD, of Auckland City Hospital (New Zealand), co-principal investigator of the study. "We are eager to explore Abbott's bioabsorbable technology as a potential clinical option for the treatment of coronary artery disease."

ABSORB is assessing the safety and performance of the stent in the treatment of patients with single de novo, native coronary artery disease or untreated lesions. Everolimus has been shown to reduce tissue growth in the coronary vessels following stent implantation, Abbott said.

John Capek, PhD, president of Cardiac Therapies for Abbott Vascular , said, "We intend to use the data from the ABSORB trial to study and develop therapies that can better serve physicians and their patient. Abbott's support of this study further demonstrates the depth of our vascular pipeline and illustrates our commitment to investing in future technologies."

Conor Medsystems (Menlo Park, California) and Biotronik AG (Bulach, Switzerland) are also developing bioabsorbable stent technologies. They have an agreement for the R&D of DES devices absorabable by the body. The technology will combine Biotronik's absorbable metal stent with Conor's vascular drug delivery stent platform, enabling tailored drug release for the treatment of restenosis and other vascular disorders.