A CDU

Abiomed (Danvers, Massachusetts) said InEK, the governmental authority for reimbursement in Germany, has granted the highest approval level available for the company’s Impella Recover devices. The new German reimbursement standard will apply to Abiomed’s Impella Recover LP 2.5, Impella Recover 2.0, Impella Recover RD and Impella Recover LD, which are available in Europe under the CE mark.

The company also said that it has recently received product registration approval in France and has now commenced shipment of Impella products to customers in that country. It said that registration of Impella products in France “provides a new opportunity for sales of [our] full Impella product line in the second-largest market in Europe.”

Hospitals in Germany are required to negotiate the reimbursement of advanced technologies and treatments directly with insurance companies. Abiomed said it received a status 1 rating, the highest available, for the Impella technology to support these negotiations and future reimbursement with German government authorities.

Michael Minogue, chairman, CEO and president, said, “Abiomed has added dedicated resources for reimbursement and economic benefit analysis in markets around the world to help accelerate patient access to technology.”

The Recover LP 2.5 is a minimally invasive ventricular unloading catheter, which is inserted percutaneously via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations.

A large percentage of patients with acute myocardial infarction require a temporary mechanical support system in order to survive. The Recover LP 2.5 can be inserted quickly into acute myocardial infarction patients and provides efficient cardiovascular support for up to five days, the company said.

The Recover LP 5.0 is a ventricular unloading catheter that is placed via a femoral artery cut-down into the left ventricle. Once in place, up to 5 liters of blood per minute is pumped from the left ventricle into the ascending aorta, actively unloading the heart.

The company said the Recover LP 5.0 has been used in European centers to support patients with post-cardiotomy failure to wean, post PCI, myocarditis, cardiogenic shock or as a bridge-to-next decision.

The Recover RD is the smallest right ventricular unloading catheter and the Recover LD the smallest left ventricular unloading catheter, Abiomed said. These devices are surgically implanted and can provide longer duration support, according to the company.

3rd-generation TriActive device gets CE mark

Kensey Nash (Exton, Pennsylvania) said it has received CE-mark approval for the third generation of its embolic protection technology, known as the TriActiv ProGuard System. It said it plans to launch the system in Europe for use in saphenous vein graft procedures by the end of 1Q06.

The TriActiv ProGuard System is designed to prevent material or debris dislodged during stent procedures from embolizing downstream and causing adverse coronary events such as a heart attack. The system includes three integrated features – an embolic protection balloon, and a combined active flush and extraction system to remove problematic debris from the target vessel.

The company said the TriActiv ProGuard System incorporates several important design enhancements to the TriActiv System platform, including Local Flush and eXtraction (LFX) technology, which allows the system to better address branched anatomy, along with a new, smaller 6F-compatible size, which it said is generally preferred by physicians, particularly in Europe.

“This is a very important product introduction for the European market,” said Joe Kaufmann, president and CEO. “The ProGuard design allows for greater utility of the system through its ability to be used in branched vessel situations and its highly desirable 6F compatibility. The flexibility of this product to be used in branched anatomy is a fundamental enhancement to the TriActiv product line.”

He said Kensey Nash now will “actively pursue” study of the platform’s utility in native coronary and leg and renal peripheral anatomies, as a complement to its ongoing study of the ProGuard system in the carotid anatomy. “We are now significantly closer to our objective of offering our physician customers in Europe a complete line of first-class embolic protection products,” Kaufmann said.

The company’s TriActiv System is cleared for sale in the U.S. The second-generation TriActiv FX System is approved for sale in the European Union. Regulatory clearance for the TriActiv FX is pending in the U.S.

CE mark for Guidant’s Xience V stent

Guidant (Indianapolis) received the CE mark for its Xience V everolimus-eluting coronary stent system in late January. The regulatory certification allows Guidant to begin marketing the drug-eluting stent in the 25 countries of the European Union. In addition, the CE mark is used to support market registrations in other regulated countries, including those within Asia, Latin America and Eastern Europe.

The Xience V system uses Guidant’s most advanced coronary stent system, the cobalt chromium Multi-Link Vision, which is available on the rapid-exchange platform the company said is preferred by physicians.

“Completion of the CE mark approval process for Xience V follows on the heels of impressive clinical results from the SPIRIT FIRST trial, which demonstrated the benefits of an everolimus drug-eluting stent,” said Patrick Serruys, MD, of the Thoraxcenter at Erasmus University Hospital (Rotterdam, the Netherlands), who served as the study’s principal investigator.

Guidant said it is ramping up manufacturing and building inventory to supply ongoing clinical trials and to support the European launch of Xience V beginning in 2Q06.

DuraSeal Sealant System gets CE mark

Confluent Surgical (Waltham, Massachusetts) said it has been granted the CE mark for use of its DuraSeal Sealant System as a surgical sealant during arterial and venous reconstructions to seal suture lines as an adjunct to standard closure techniques. The company said DuraSeal Sealant offers surgeons “a valuable tool to reduce bleeding from the suture line in bypass procedures, as an example, and to prevent post-operative complications associated with suture line bleeding.”

The DuraSeal technology is a synthetic, absorbable hydrogel delivered by a dual-syringe applicator. The device can be stored at room temperature and prepared in less than two minutes. Confluent said the DuraSeal Sealant “polymerizes within seconds when sprayed on the suture line.” After several weeks, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys.

The company said a feature unique to the sealant is the blue colorant, “[which] provides the vascular surgeon excellent visualization of coverage and thickness of the material upon application.”

“Consistent, immediate sealing of the suture line to prevent bleeding has to date been an elusive goal in various vascular bypass procedures,” said Sean O’Donnell, MD director of the section of vascular surgery at Washington Hospital Center (Washington). “This sealant is easy to apply, adheres well to tissues and graft materials and is a very valuable adjunct to achieving hemostasis, especially in patients who are on antiplatelet agents in addition to their anticoagulation.”

Confluent said it plans to begin a U.S. vascular sealing study this year.

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