A Medical Device Daily

AGA Medical (Plymouth, Minnesota) said it has received CE-mark approval for the Amplatzer Duct Occluder II (ADO II) and has launched the device in Europe.

The company said the ADO II expands its family of occlusion devices designed to occlude or close a patent ductus arteriosus (PDA), a type of congenital heart defect that occurs when the ductus arteriosus blood vessel fails to close after birth, as it normally should.

“We believe the new ADO II represents a development milestone for AGA Medical and demonstrates the success of our product development programs,” said Franck Gougeon, president/CEO. “It is our first approved occlusion device designed to treat structural heart defects that does not include fabric to assist in rapid occlusion. This expands the type of ducts that can be closed by our family of PDA devices.”

The ADO II is a self-expanding nitinol mesh device and is designed to be introduced in a minimally invasive fashion through a catheter. The device has two retention disks positioned on either side of the duct and connected by a waist. The device is designed with a screw mechanism for attachment to the deployment cable that allows the device to be withdrawn and repositioned, if necessary, prior to release from the cable.

The device treats a patent ductus arteriosus, an open channel in every fetus that allows blood to bypass the lungs, and is no longer used when the baby takes its first breath after birth. AGA said that shortly after the baby’s first breath, the ductus arteriosus should close permanently.

“If it does not close, it is known as a PDA. This condition can cause symptoms such as fatigue, difficulty or rapid breathing, failure to grow normally, or chronic respiratory infections such as colds and pneumonia, or endocarditis.”

“The ADO II greatly improves treatment options for babies and young children because it can be used with very small diameter catheters,” Gougeon said.

The original Amplatzer Duct Occluder received the CE mark in 1998 and was approved by the FDA in 2003. It is currently under review by Japanese regulatory authorities.

AGA develops devices that it said have “revolutionized” the treatment of the most common congenital holes in the heart such as atrial septal and patent foramen ovale defects. The company also is expanding into new areas such as the minimally invasive repair of vascular abnormalities.

Enrollment under way in ‘olimus’ registry

Boston Scientific (Natick, Massachusetts) said the first patient has been enrolled in its PROmus, ENdeavor and CYpher (PROENCY) European registry.

The company said the registry is the first to observe different “olimus”-eluting coronary stents. It will collect real-life clinical outcome data for Boston Scientific’s Promus everolimus-eluting coronary stent and compare them with data from Johnson & Johnson’s (New Brunswick, New Jersey) Cypher sirolimus-eluting stent and Medtronic’s (Minneapolis) Endeavor zotarolimus-eluting stent in patients in routine clinical practice.

The Promus stent is the Xience V everolimus-eluting coronary stent system manufactured by Abbott (Abbott Park, Illinois) and also distributed by Boston Scientific under a private-label agreement.

The Promus is an investigational device in the U.S., with its premarket approval application being reviewed by the FDA.

“I am excited to enroll the first patient into this innovative new registry,” said principal investigator Christian Hamm, MD, of Kerckhoff Heart Center (Bad Nauheim, Germany). “We have previously seen efficacy data from clinical trials with the Promus, Cypher and Endeavor stents, but data from this registry will allow us, for the first time, to comparatively assess the differences between everolimus-, sirolimus-, and zotarolimus-eluting stents in patients with simple and complex lesions.”

He added: “This should help clinicians in making the appropriate stent choice for their patients.”

The registry will enroll up to 2,500 patients with simple and complex lesions at multiple sites in several European countries. Of the patients at each site, half will receive the Promus stent and half will receive either the Cypher or the Endeavor stent from Medtronic (Minneapolis) to attain a 2:1:1 ratio of Promus, Cypher, Endeavor stents, respectively.

The primary endpoint of the registry will be the rate of major cardiac events (cardiac death, all myocardial infarction and target vessel revascularization) at 12 months.

The Promus, Cypher and Endeavor stents have previously been investigated in randomized clinical trials. Boston Scientific said 12-month data from the SPIRIT III Trial, presented last October at the Transcatheter Cardiovascular Therapeutics conference in Washington, “confirmed earlier positive clinical results for the Xience V (Promus) stent.”

Aerocrine adds to patent portfolio

Aerocrine (Solna, Sweden) said it has strengthened its patent portfolio by acquiring a strategically important patent and patenting its own discoveries.

The company said the acquired patent describes how to electronically control the flow of exhaled air when measuring nitric oxide. “Repeated exhalation with different airflows allows airway inflammation to be localized peripherally or centrally,” it said. “This could be highly significant both for diagnosis and when choosing medication for patients with asthma-like symptoms, and in cases of suspected COPD.”

The discovery comes from a research group at the University of Tampere in Finland. Aerocrine uses this new technology in its latest product, Niox Flex.

The company said it also has gained approval in the U.S. for the first patent in a completely new patent family. This patent involves a way of measuring whether patients who have undergone polyp surgery have improved nasal flow-through.

Aerocrine, which said its patents are distributed over three business areas and 13 separate patent families, describes itself as “a clinically based company dedicated to improved asthma management and care.”

The company is marketing Niox Flex on a worldwide basis and also is marketing Niox Mino, representing a new generation of hand-held devices, in Europe.

Both products are tailored for rapid, non-invasive control of the inflammatory status in the airways.

In addition to its facilities in Sweden, Aerocrine has subsidiaries in the U.S., UK and Germany.