A Medical Device Daily

ITGI Medical (Or Akiva, Israel), a developer of tissue-covered stents, has reported the launch of its Over and Under Pericardium Covered Stent (PCS), in the UK, Switzerland and Ireland.

Over and Under is a stent covered with a heterologous tissue, designed to set a barrier between the coronary blood vessel wall and its lumen. It is intended for situations such as degenerated saphenous vein grafts (SVG), aneurysms and perforations.

The first in a planned series of heterologous tissue-covered stents, Over and Under is indicated for treatment of bypass stenosis, aneurysms and for emergency situations such as perforations.

"There is great unmet medical need for stents that are 100% covered, biocompatible and flexible," said Haim Danenberg, MD, head of the interventional cardiology unit and the company's medical director. "[The] Over and Under PCS is a breakthrough product that would provide the interventional cardiolog[ist] the ability to separate the blood from the vessel wall while minimizing adverse events."

Company CEO Efri Argaman said the Over and Under stent "is especially suitable for patients with degenerated SVG, where the lesions are less calcified than those in native coronaries. Over and Under, as [with] the rest of our heterologous covered stents, brings a new message to the interventional medicine and the therapeutic solutions the physicians can provide their patients."

At its initial step, ITGI is launching Over and Under PCS in the UK, one of the largest target markets in Europe, in collaboration with Pyramed, the company's UK distributor.

ITGI also is launching its sales in Ireland together with its local distributor, Lecks Medical, and in Switzerland through Euromed Endovascular.

Covidien launches hernia repair mesh

Global healthcare products provider Covidien (Hamilton, Bermuda) reported the European introduction of the AbsorbaTack 5 mm absorbable mesh fixation device for hernia repair, which is one of the most widely performed surgical procedures worldwide.

The company said the AbsorbaTac 5 mm absorbable tacks "provide strong mesh attachment to the surrounding tissues, while reducing the amount of foreign material remaining in the patient long-term."

It said that coupling the absorbable fixation of the AbsorbaTack with its Parietex mesh, a hydrophilic polyester mesh that establishes "fast, intimate tissue integration," offers an "appropriate" clinical solution.

"We are changing the way surgeons approach soft tissue repair," said Scott Flora, president of Covidien's Surgical Devices business. "The success of this new device will strengthen [our] position ... providing comprehensive solutions for hernia repair."

The European launch follows the January introduction of AbsorbaTack in the U.S. "Absorbable fixation that is as effective and easy to use as ... ProTack is ideal," said Bruce Ramshaw, MD, associate professor and chief of the division of general surgery at the University of Missouri. "Since AbsorbaTack is a 5 mm device, we can use it for the laparoscopic ventral hernia as well as a laparoscopic inguinal repair."

Spiration signs Olympus to distribute IBV Valve

Olympus Medical Systems (Tokyo) and Spiration (Redmond, Washington) have signed a definitive agreement granting Olympus exclusive marketing and distribution rights in Europe for Spiration's IBV Valve System. Olympus will launch the product in select European countries late this year.

The IBV Valve System is a minimally invasive treatment that has diverse applications for both acute and chronic conditions of the lung. In Europe, the system has received market clearance through the CE mark for diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of prolonged air leaks, a complication that can occur following lung surgery.

The IBV Valve System was developed as a treatment alternative for emphysema patients who do not respond well to current medical therapies or are not eligible for invasive surgery such as lung volume reduction or lung transplantation.

The system also may be used to resolve prolonged air leaks that can occur following lung surgery.

For the treatment of emphysema, the IBV Valve System is designed to redirect airflow from diseased portions of the lung to healthier areas. During the minimally invasive procedure, a catheter is passed through a bronchoscope to deploy the small umbrella-shaped valves into the airways of the upper lobes of the lungs.

Under the agreement, Olympus and its distributors will have exclusive marketing and distribution rights for the IBV Valve System in 43 European countries, including the UK and countries belonging to the European Union.

Spiration will manufacture the product and the device initially will be marketed under the Spiration name. Financial terms of the agreement were not disclosed.