A Medical Device Daily

Angiotech Pharmaceuticals (Vancouver, British Columbia) said it has received CE-mark approval for its Quill Self-Retaining System (SRS). Launched early this year in the U.S., Quill SRS is expected to launch commercially in Europe in mid-year.

"With the potential to improve patient outcomes, save time in the operating room and enhance procedural techniques, Quill SRS represents the next generation in wound-closure technology," said Dr. William Hunter, president/CEO of Angiotech. "In the first three months of launch in the U.S., we have seen strong physician interest in this product and expect similar reception in Europe."

Dr. Santi Corsaro, VP, sales and marketing in Europe, said, "We believe that Quill has a unique advantage, as its self-retaining system allows for wound closure without the need for knots. With the approval of Quill SRS in Europe, as well as the expected approval of the Vascular Wrap product later this year, we are starting to build our sales and marketing infrastructure to support these two important franchises."

The company said Quill SRS's helical barbed design enables surgeons to suture without the use of knots, which achieves potentially significant time savings in the operating room, especially in suture-intensive procedures

Separately, Angiotech reported that it has amended its agreement with Edwards Lifesciences (Irvine, California) regarding the European distribution of Angiotech's Vascular Wrap, a paclitaxel-eluting mesh/ePTFE graft combination product.

Angiotech now has the exclusive rights to distribute the Vascular Wrap/ePTFE graft combination product through its own sales force and distribution network in Europe. Edwards still retains the same marketing and distribution rights with respect to the stand-alone Lifespan vascular graft product line as outlined in the original agreement.

"At the time of the initial agreement [with Edwards], we lacked the commercial infrastructure to distribute products ourselves, but since then we have grown significantly and have added the capability to access the EU market directly through our own sales and distribution network," said Hunter.

"Based on the recent positive results from our two-year European study, we believe that the Vascular Wrap product will be a key catalyst for Angiotech going forward," he said, adding, "we felt it was imperative that we establish our presence and brand in this market right from the initial launch date.".

"Launching the Vascular Wrap product under our own name and through our own commercial group is an important step for us in building this significant vascular franchise at Angiotech," said Corsaro. "By becoming the exclusive distributor of our Vascular Wrap/ePTFE graft combination product in Europe, we can take full control of the European marketing strategy for this key product, as we are rapidly building our own sales and distribution network."

Angiotech acquired the Lifespan ePTFE vascular graft business from Edwards in December 2005. The transaction included a distribution agreement whereby Edwards was given the rights to distribute the stand-alone Lifespan ePTFE vascular graft product line in Europe and the U.S, as well as Angiotech's Vascular Wrap/ePTFE graft combination product in Europe.

Following that transaction, Angiotech acquired its own sales force and distribution infrastructure through its March 2006 acquisition of American Medical Instrument Holdings (Minnetonka, Minnesota).

Sorin releases Reply pacemakers

Sorin Group (Milan, Italy) reported European market release of its next-generation Reply pacemakers, calling them the world's smallest dual-chamber pacemakers, at 8 cc.

The Reply pacemakers integrate Sorin's SafeR pacing mode, which constantly monitors the patient's natural cardiac activity and reduces the amount of pacing delivered to the right ventricle, thereby promoting natural cardiac function.

Andre Michel Ballester, president of Sorin's Cardiac Rhythm Management (CRM) unit, said, "[We have] pioneered significant technological firsts in the management of cardiac arrhythmias and heart failure, with a view to bringing clinical benefits to patients and their physicians. We … have developed a new pacemaker family that builds on our legacy of innovations."

Regulatory clearance in the U.S. and Japan is expected in early 2008.

Sorin said delivering unnecessary pacing to the right ventricle has been shown to "significantly enhance" the risk of patients developing heart failure and atrial fibrillation. It said SafeR reduces pacing in the ventricle to 0.1% in patients without heart block. "Furthermore, recently published results have shown that patients with different degrees of heart block may also benefit from this pacing mode."

Sorin said that SafeR technology builds on its AAIsafeR mode, the first pacing mode designed to limit unnecessary ventricular pacing that was available in a pacemaker. AAIsafeR was first launched in September 2003 in Europe and received FDA approval in May 2005.

In addition to SafeR, the Reply pacemakers bring together automatic features that offer easier patient management by streamlining device checks. Because all programming data needed for follow-up can be obtained from one touch on the programmer's screen, up to 25% of follow-up time can be saved, the company said.

CE mark for ReValving System

CoreValve (Irvine, California) said it has received the CE mark for its CoreValve Percutaneous ReValving System for treatment of high-risk patients. The ReValving System consists of a porcine pericardial tissue valve mounted in a self-expanding multi-level frame, which is permanently implanted over the diseased aortic heart valve by an 18 Fr-sized catheter.

The ReValving System procedure is intended to avoid open-heart surgery. It can be performed in a cardiac cath lab just like angioplasty and stenting, which, according to the company, may result in less patient trauma and offer "substantial cost savings" to the healthcare system.

CoreValve said the small size of the delivery catheter is a "key element" of the system, "as it greatly improves overall maneuverability and valve placement while also eliminating the need for surgical cut-down of the femoral artery."

The company said that it will not immediately market the ReValving System, proceeding instead with an expanded clinical evaluation at "a small number of select international centers" to help ensure that interventional cardiologists are well-trained, that patients are appropriately selected for treatment, and that appropriate clinical feedback is obtained.

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