Med-techs extend borders seeking new opportunities

Medical device companies, eager to drive growth, are now increasingly seeking new opportunities – and approvals from regulators – throughout the world. Three recent examples of companies extending their reach across borders include: U.S.-based Abiomed garnering approval in India for three heart pumps; I. Ceram, a French company, achieving CE mark certification in Europe for its porous alumina sternal implant; and the FDA giving the nod to U.K.-based Endomagnetics for a magnetic device system for guiding lymph node biopsies in breast cancer patients undergoing mastectomy.

This article features excerpts from a collection of recent regulatory updates from BioWorld MedTech, the daily medical device and diagnostics news service from Clarivate Analytics.

 

Abiomed wins Indian approval for Impella heart pumps

Abiomed Inc. received approval for its Impella 2.5, Impella CP and Impella 5.0 heart pumps from the Central Drugs Standard Control Organization (CDSCO) in India.

The heart pumps have been green lighted for use during high-risk percutaneous coronary intervention (PCI), cardiogenic shock, and other reduced left ventricular function conditions.

The Danvers, Mass.-based Abiomed plans to introduce the products to the Indian market via its Heart Recovery Program.

“We are working with committed physicians and limited Centers of Excellence in India, starting in New Delhi and Jaipur, to learn and adapt best practices to the local environment. We are driven by our mission to recover hearts and save lives by bringing Impella heart pumps closer to patients,” Michael Minogue, chairman, president and CEO of Abiomed, told BioWorld MedTech.

 

We are driven by our mission to recover hearts and save lives by bringing Impella heart pumps closer to patients.”

– Michael Minogue, chairman, president and CEO of Abiomed, to BioWorld MedTech

To read the full article, download our September 2018 MedTech update here.

 

I.Ceram launches first bioceramic sternal implant in European market

I.Ceram SA has achieved CE mark certification for its first new-generation implant: the Ceramil porous alumina sternal implant.

André Kérisit, CEO of Limoges, France-based I.Ceram, told Bioworld MedTech, “This European certification confirms the implant’s biocompatibility, osteointegration and radiolucency properties, making it the reference device for sternal reconstruction surgery.”

This technology is intended for patients who have developed cancer of the sternum through metastasis or from radiotherapy used to treat breast cancer, as well as for those born with a complete sternal cleft. This translates into a population across Europe of 2,500 patients a year, and the same in the U.S. Until now, thoracic surgeons had just two prosthetic options available to them. The first involves replacing the sternum with a titanium prosthetic, while the second relies on construction during surgery of a bespoke part using bone cement (polymethyl methacrylate or PMMA) and metal fixings. Both these conventional options increase patient infection risk. Furthermore, they do not maintain elasticity of the rib cage needed for unimpaired respiratory function.

Our Ceramil technology is the only one allowing osteointegration, where the bone is still alive and grows in and around our material.”

– André Kérisit, CEO of Limoges, France-based I.Ceram, to Bioworld MedTech

To read the full article, download our September 2018 MedTech update here.

 

FDA gives nod to Endomag’s system for guiding sentinel lymph node biopsies

Cambridge, U.K.-based Endomagnetics Ltd. (Endomag) secured FDA approval for a magnetic device system for guiding lymph node biopsies in breast cancer patients undergoing mastectomy.

The Magtrace and Sentimag magnetic localization system uses magnetic detection to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal. The system includes a magnetic sensing probe and base unit designed to detect small amounts of Magtrace, the tracer drug that is injected into breast tissue. The particles travel to lymph nodes and become trapped in them. Subsequently, the Sentimag probe is applied to the skin in areas closest to the tumor site containing the lymph nodes. The sensing of the magnetic particles is indicated by changes in audio and visual alerts from the base unit. Surgeons may move the handheld probe to help locate the sentinel lymph node or nodes. Once identified, a small incision is made to remove the node, which is checked by a pathologist for the presence of cancer cells. For patients, testing these nodes indicates whether their cancer has spread.

Mathew Stephens, Endomag commercial director, told BioWorld MedTech that Magtrace is the only tracer that can be injected days or weeks before the surgery, without marking any higher echelon nodes. As a result, the patient experience is enhanced and scheduling becomes more precise.

 

Read the September 2018 MedTech update.

 

This article was excerpted from a new compilation of regulatory updates written by BioWorld MedTech Staff Writers Bernard Banga, based in Paris; David Ho, based in Hong Kong; and Liz Hollis, based in the U.S. BioWorld MedTech is the global news service providing med-tech updates and analysis from Clarivate Analytics. To access the full report, please click here.

For more information about BioWorld MedTech and to learn how you can subscribe today, visit: Clarivate.com/products/bioworld-medtech.

And watch for BioWorld MedTech’s in-depth coverage of the MedTech Conference next week!

 

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