Medical Device Daily European Correspondent

BARCELONA — Two weeks after reporting dismal results against a key competitor in clinical trials for a next-generation drug-eluting stent (DES), Johnson & Johnson (J&J; New Brunswick, New Jersey) bounced back at the EuroPCR meeting with announcements of new product launches and a broad-based strategy to reassert its growing emphasis on cardiovascular device development.

Rick Anderson, company group chairman, came here to Europe's largest gathering of interventional cardiologists to present analysts with what he called "a path forward to grow our business outside of DES."

That path hit a roadblock in early May with the report by Conor Medsystems (Menlo Park, California) that its COSTAR II study had failed to meet its primary endpoint of non-inferiority to the Taxus from Boston Scientific (Natick, Massachusetts) (Medical Device Daily, May 8, 2007). This constituted a critical and clinical setback for J&J which had acquired Conor earlier this year in a $1.4 billion deal in an attempt to bolster its first-generation DES product, the Cypher from its Cordis (Miami Lakes, Florida) subsidiary, with Conor's stent, touted as having a more advanced drug-eluting architecture (MDD, Feb. 5, 2007).

"To this point we have been technology-driven and DES-centric," Anderson said, in unveiling the company's vision to create a "global enterprise to defeat cardiovascular disease."

Non-DES sales in 2006 for the group were $1.5 billion, or 36% of total sales of $4.1 billion, he said.

Anderson said the company's cardiovascular franchise — which includes Cordis, Conor and Accelerated Medical Ventures (Fremont, California) — will pursue a broad-based approach "to secure substantial leadership positions in atrial fibrillation and peripheral vascular disease. We will also continue our efforts in the area of structural heart disease."

He then added: "Yet we need to remain very competitive in stents," thereby introducing the company's unveiling of an exclusive worldwide distribution agreement between Cordis and Medinol (Tel Aviv, Israel) for a family of bare metal stent (BMS) devices.

(Significantly, the agreement repositions Medinol in its U.S. corporate alliances following its failed partnership with, and resulting acrimonious litigation vs. Boston Scientific earlier in the decade.)

Cordis and Medinol said they will collaborate to win regulatory approvals for two stent products:

  • A cobalt chromium stent with enhanced scaffolding and a thickness of 75 microns is expected to be submitted for approval in the second half of this year.
  • A stainless steel stent with a strut thickness of 90 microns is expected to be submitted for approval in the first half of 2008.

Putting the accent on a "robust pipeline portfolio of products" in late-stage development, Anderson said nine new products will be introduced this year as the company repositions strategy with a vision to address a continuum of market needs for cardiovascular devices beyond DES.

Three guidewires in the Regatta family will be introduced this year through an exclusive distribution agreement with Brivant (Galway, Ireland). Two dilation catheters, Fire Star and Dura Star, are expected.

A product under development for outside the U.S. is the transradial access kit for cardiologists preferring an alternative to the traditional transfemoral access.

The acquisition of Ensure Medical (Sunnyvale, California) last July by Cordis will give Cordis an entrée into the vascular closure device market (MDD, July 14, 2006). Ensure has developed a device for post-catheterization closure of the femoral artery, now named Exoseal, a bioabsorbable plug implant receiving positive feedback from investigators.

The pivotal clinical study ECLIPSE has reached 50% enrollment, the company said, with CE mark filing expected yet this year and a U.S. pre-market approval application filing expected next year.

A percutaneous patent foramen ovale (PFO) closure device is of "tremendous strategic importance to Cordis, said Campbell Rogers, MD, chief technology officer for J&J's cardiovascular group. Deliverable over-the-wire the device can unfurl to accommodate a range of pocket lengths with a nitinol mesh that promotes tissue adhesion and creates an immediate barrier to emboli. CE-mark trial initiation is planned for the first half of 2008.

Finally, Rogers said there is a "tremendous focus in the percutaneous heart valve therapy space" with products for mitral valve repair and aortic replacement. Neither timelines nor specific products were mentioned, but Rogers said, "Needless to say, we are pursuing both internal development and external partnership opportunities."

Meanwhile, returning to the opportunity in stenting, Rogers previewed for analysts future DES applications using the Conor reservoir technology and line extensions for the Cypher Elite.

Cypher will be enhanced with a new scaffolding design and advanced surface-coating techniques for drug delivery.

A pivotal randomized trial with just under 2,000 patients is planned to run in parallel with non-randomized trials for expanded indications. Based on current FDA regulations the timeline calls for PMA submission in 2H09.

Cordis will return to sirolimus for the innovative reservoir technology of the Conor coronary stent platform, abandoning palitaxel after the CoStar II trial misadventure.

Through Cypher, Cordis has a strong track record with sirolimus, Rogers pointed out, with demonstrated efficacy over five years through 70 studies, 45,000 clinical trial patients and nearly 3 million devices implanted worldwide.

Rogers said that "active efforts" are underway to study and develop solutions for what he termed the "incredible power of the Conor reservoirs that permits customized, complex drug delivery inlays."

Future development opportunities for reservoir-based drug delivery include peripheral vascular disease, neurovascular, orthopedics, ophthalmology and oncology, he said.

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