iSTAR Medical MINIject

Fusion Marketplace Changes Healthcare Traveler Experience

Fusion Marketplace is a traveler-first driven platform giving healthcare professionals the power to make decisions in their careers that they haven't been able to in the past.

Veranex Announces Investment From Summit Partners to Form Comprehensive Concept-to-Commercialization Medtech Services Company

As the first phase in building this global entity, Veranex has acquired three complementary solution providers: Ximedica, Quartesian, and Boston Healthcare Associates. By bringing these companies together, Veranex combines the industry’s key pillars of design and engineering, regulatory, clinical, and market access into a single-source solution.

iSTAR Medical SA, announced consistent 18-month results of the first-in-human,micro-invasive glaucoma surgery (MIGS) STAR-Itrialfor the MINIject(TM) device in a standalone setting. These results confirm the stability and sustained performance of MINIject beyond the first year.

The STAR-I trial demonstrated that the implantation of MINIject resulted in a mean pressure of 15.0mmHgat 18-months, consistent with results reported at 1 year, and at a level expected to reduce the progression of glaucoma. In addition, almost two-thirds of the patients were able to stop taking their eye drops. These results confirm that the safety and effectiveness of MINIject is sustained over time, with minimal patient-management required.

Dr Ike Ahmed, University of Toronto, Ontario, Canada, who performed some of the first MINIject procedures in theSTAR-I trial, commented: “The stable pressure between 1 year and 18 months is reassuring as to the sustained performance of MINIject over time. MINIject’s STAR material and its use in the supraciliary space is a promising combination.

”Early six-month results of MINIject in the STAR-I trial were published online in June in Ophthalmology-Glaucoma, the journal of the American Glaucoma Society (AGS). The 18-month results of MINIject will be presented in detail on Friday, 13 September 2019, during Glaucoma Day at the ESCRS congress in Paris, France.

Michel Vanbrabant, CEO of iSTAR Medical, added: “iSTAR Medical setting new frontiers in MIGS treatment of glaucoma. We are thrilled to see MINIject’s powerful and reliable efficacy in a standalone procedure sustained over time, without a trade-off between safety and efficacy, and without requiring invasive follow-up procedures or surgeries.We look forward to bringing this therapeutic option in the supraciliary space to market for glaucoma patients.”iSTAR Medical has also completed enrolment in STAR-II, a pivotal European trial. The results of STAR-II will support the application for CE-Marking for MINIject, which is expected in 2020.

spot_img

DON'T MISS

Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles