Cerus Endovascular Receives CE Mark Approval for its Contour Neurovascular System™

Designed to Treat Intracranial Aneurysms Reports Cerus Endovascular

The Contour Neurovascular System™ is used for the treatment of intracranial aneurysms. The Contour Neurovascular System ™ is a unique, fine mesh braid that is deployed across the neck of the aneurysm sac and provides a combination of flow diversion and flow disruption through a single device implant. Commercial sales, via a controlled market release across the European Union (EU), are expected to begin during the second quarter of 2020.

CE Mark approval was based on data generated from the company’s two EU studies evaluating the safety and efficacy of the Contour Neurovascular System™, focusing on unruptured intracranial aneurysms. The latest, completed in 2019, was conducted at six sites in Germany, Austria, and Denmark, while the earlier study included four sites in the United Kingdom and Hungary. Data from the first study has been presented at a number of scientific conferences in early 2020, while data from the second, most recent study will be presented later this year.

“As our clinical data experience grows, and more physicians use the System, results continue to be compelling – providing additional confirmation that the Contour Neurovascular System™ delivers an important clinical option and represents a new, and potentially disruptive, standalone solution for the treatment of bifurcated saccular intracranial aneurysms compared to currently available technologies,” stated Dr. Stephen Griffin, President of Cerus Endovascular. “Importantly, physicians who have used the System have highlighted the benefits inherent in its unique simplicity, including a simple sizing approach of the device to the aneurysm width, ease of deliverability and controlled deployment.”

“Congratulations go out to the entire company, including our new management team, who were instrumental in pushing these studies forward, leading to our first regulatory approval and the achievement of a number of other, as yet unannounced, key milestones,” stated Dr. Sam Milstein, Chairman of Cerus Endovascular. “CE Mark approval, a critical step in our go-to-market strategy, has propelled us from the research and development stage to a  commercial-stage company, and we are eager to begin this next phase by making the Contour Neurovascular System™ available to physicians and patients across the EU in a controlled roll-out.”

Medical Device News Magazinehttps://infomeddnews.com
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Data from clinical studies of STK-001 demonstrated clinical benefit for patients ages 2 to 18 years old, including reductions in seizures and improvements in cognition and behavior that support the potential for disease modificatio. Analysis of 72 patients treated in STK-001 clinical trials suggests that higher STK-001 drug exposure in brain leads to greater seizure reductions. Two-year data from the longest prospective natural history study of Dravet syndrome showed that, on average, patients experienced no meaningful improvement in convulsive seizure frequency and exhibited widening gaps in cognition and behavior despite treatment with the best available anti-seizure medicines.
"Exact Sciences is looking forward to presenting new evidence at SABCS that adds important perspectives to treating breast cancer patients and showing that some patients may be able to de-escalate treatments and still have positive outcomes," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology, Exact Sciences. "Every year, we build upon the precedent set by the Oncotype DX Breast Recurrence Score® test and its prognostic and predictive abilities to determine the chemotherapy benefit for specific breast cancer patients. We are pleased to see authorities expanding access to this test as we continue to develop key evidence in collaboration with some of the world's most prestigious, breast cancer-focused organizations."
Clozapine has been established as the most effective antipsychotic medication for treatment-resistant schizophrenia. However, it is significantly underutilized mainly due to the risk of developing agranulocytosis and the need to frequently monitor the absolute neutrophil count (ANC).
Dagi-Ben Noon, CEO of Inspira Technologies, reflects on the partnership's significance: "By Integrating our technology to oxygenate blood directly with Ennocure's infection prevention solutions, we are focusing on potentially improving patient outcomes in ICUs and paving the way for safer, more effective life-support treatments. This collaboration is expected to accelerate the development and broaden the implementation of our advanced technology."
The findings suggest that the novel, non-invasive genomic test can help physicians guide next steps for these patients, enabling them to potentially avoid unnecessary invasive procedures or accelerate time to appropriate treatment.

By using this website you agree to accept Medical Device News Magazine Privacy Policy