Boston Scientific Corp. (NYSE:BSX) is touting the U.S. release of its Ion drug-eluting stent system as the first step toward bolstering its leadership position in the DES market.
The Ion paclitaxel-eluting stent, which is built on Boston Scientific’s next-generation platinum-chromium Element platform, won FDA approval for commercial release in the U.S. The stent, already available in Europe under the Taxus Element label, brought in just under $90 million in sales last quarter.
Officials at the Natick, Mass.-based medical device maker said the Ion stent uses a “platinum chromium alloy designed specifically for coronary stenting and intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease,” according to a prepared release.
The Ion, coupled with the projected release of the Promus Element everolimus-eluting stent next year, is expected to help BSX increase its 46 percent market share stateside, according to company officials. BSX CFO Jeffrey Capello said last week in a conference call with analysts that the company maintains a healthy lead over its competitors at Abbott (NYSE:ABT), Johnson & Johnson’s (NYSE:JNJ) Cordis Corp. and Medtronic (NYSE:MDT).
“Abbott’s share was approximately 31 percent, while J&J and Medtronic achieved approximately 10 percent and 13 percent, respectively,” Capello estimated during the call. The total U.S. market for drug eluting stents was about $422 million during the first quarter; according to Capello, that’s about 8 percent smaller than it was during the same period a year ago. BSX saw its own sales of drug-eluting stents drop to $189 million, 13 percent lower than the comparable period in 2010.
Taxus sales make up about 26 percent of the company’s DES sales in the U.S.
“Coupled with both our commercial strength [and] the challenges facing one of our competitors, we believe we are very well positioned to take share in the U.S. with the introduction of the Ion stent,” Capello said. “This will position us very well in the marketplace for our planned launch of Promus Element, which is on or ahead of schedule for a mid-2012 launch.”
The company believes the worldwide DES market to be just north of $1 billion, Capella noted, with BSX controlling an estimated 36 percent, an 8 percent edge over its closest competitors.
For its part, Wall Street seems to be in agreement. Shares of BSX were up about 1.7 percent and trading at about $7.28 by the late afternoon.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- HeartWare wins approval for VAD update in U.K.
HeartWare International Inc. (NSDQ:HTWR) received notification from the British Standards Institution (BSI) that the company’s supplemental addendum for the HeartWare ventricular assist device requesting “the addition of a sintered inflow tube” was accepted as a supplement to the CE Mark for its HVAD System. Sintering titanium is a process by which minute beads are metallurgically affixed to a titanium surface and is commonly used in medical devices to facilitate tissue adhesion at the sintered region. In the U.S., the FDA previously approved the introduction of a sintered inflow tube for both the company’s destination therapy clinical trial, ENDURANCE, as well for the Continued Access Protocol of the company’s Bridge-to-Transplant study, ADVANCE.
Read more - STAAR Surgical wins CE Mark for implantable eye lens
STAAR Surgical Co. (NSDQ:STAA), a developer of minimally invasive ophthalmic lenses for refractive surgery,announced CE Mark approval for its Visian Implantable Collamer Lens (ICL) V4c design. The V4c design incorporates a proprietary port in the center of the ICL optic of a size determined to optimize the flow of fluid within the eye, and eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant. Both myopic and myopic toric models of the ICL will feature the new design. The company has two issued patents on the technology to enhance flow within the eye and is pursuing additional claims to further broaden its intellectual property position.
Read more - CSI Labs wins COG approval for cytogenetic testing
CSI Laboratories, a private national cancer diagnostics laboratory, has received approval from the Children’s Oncology Group (COG) to begin analyzing pediatric cytogenetic cases. The Children’s Oncology Group is the world’s largest children’s cancer research organization and includes more than 210 member hospitals with over 6,500 medical professionals. CSI received COG approval by showing a cytogenetic abnormality rate of 73 percent on submitted pediatric acute lymphoblastic leukemia cases. This far exceeded the required rate of 55 percent.
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