Vascular diseases

Endologix Receives CE Mark for ALTO Abdominal Stent Graft System

Retrieved on: 
Wednesday, August 5, 2020

Transforming the treatment of aortic disorders, Endologix Inc. (OTC: ELGXQ) (Endologix or the Company), today announced that it has received a CE Mark for the ALTO Abdominal Stent Graft System (ALTO).

Key Points: 
  • Transforming the treatment of aortic disorders, Endologix Inc. (OTC: ELGXQ) (Endologix or the Company), today announced that it has received a CE Mark for the ALTO Abdominal Stent Graft System (ALTO).
  • We are very excited to receive a CE Mark for the ALTO system, that has been achieved through a strong partnership and collaboration with our European notified body, NSAI commented Matt Thompson, Chief Medical Officer of Endologix.
  • In addition, with ALTO, we anticipate observing improved short-term outcomes relative to the Ovation iX Abdominal Stent Graft System (Ovation iX) as a result of the design and manufacturing changes incorporated into ALTO.
  • Lastly, CE Mark of the ALTO system is yet another critical milestone for Endologix as we seek to introduce a portfolio of devices to address the current unmet needs of endovascular aneurysm repair (EVAR).

Cerus Endovascular and Balt Enter Strategic Distribution Agreement for Innovative Neurovascular Devices to Treat a Range of Intracranial Aneurysms

Retrieved on: 
Tuesday, August 4, 2020

We are excited to begin working closely together and eventually, to extending the distribution agreement into other key EU countries."

Key Points: 
  • We are excited to begin working closely together and eventually, to extending the distribution agreement into other key EU countries."
  • "Balt has a long history of delivering innovative, life-saving devices to the hands of physicians.
  • The Company's CE Marked products, the Contour Neurovascular System and the Neqstent Coil Assisted Flow Diverter, expand the number and types of treatable intracranial aneurysms.
  • Since it was established in 1977, Balt has worked with interventional physicians to develop devices to treat complex life-threatening neurovascular conditions such as ischemic strokes, aneurysms and arteriovenous malformations.

Stryker's Neuroform Atlas® Stent System granted an expanded indication, providing a new option for patients with aneurysms in the back of the brain

Retrieved on: 
Monday, August 3, 2020

With the approval of the Neuroform Atlas adjunctive stent for the posterior circulation, long term treatment is more feasible.

Key Points: 
  • With the approval of the Neuroform Atlas adjunctive stent for the posterior circulation, long term treatment is more feasible.
  • The combined patients from both the anterior and posterior cohorts totaled 298 patients, making it the largest study of its kind.
  • "Posterior stent assisted coiling with Neuroform Atlas achieved an impressive high rate of complete occlusion in this very challenging location at 76.7%.
  • Stryker's Neuroform Atlas Stent System is a self-expanding nitinol stent used in conjunction with metal coils to pack weakened blood vessel sacs called aneurysms within the brain.

Endologix Announces First Commercial Implant of ALTO Abdominal Stent Graft System & Official Start of U.S. Commercial Release

Retrieved on: 
Thursday, July 30, 2020

ALTO represents a differentiation from traditional endovascular aneurysm repair (EVAR) and, with its introduction, a significant landmark for Endologix.

Key Points: 
  • ALTO represents a differentiation from traditional endovascular aneurysm repair (EVAR) and, with its introduction, a significant landmark for Endologix.
  • With its unique anatomically adaptive sealing technology, ALTO offers patients improved acute outcomes and the ability to preserve long-term durability.
  • ALTO offers a workhorse endograft with broad indications to treat the widest range of patients.
  • The first commercial implant marks the official start of the U.S. release of the ALTO Abdominal Stent Graft System.

InspireMD Gains Registration Clearance of its CGuard™ Embolic Prevention System (EPS) in Brazil

Retrieved on: 
Thursday, July 23, 2020

Regulatory approval of CGuard EPS in Brazil reflects not only the ANVISA'S recognition of CGuards differentiating features versus conventional carotid stents, but also the need for safer treatments for carotid artery disease.

Key Points: 
  • Regulatory approval of CGuard EPS in Brazil reflects not only the ANVISA'S recognition of CGuards differentiating features versus conventional carotid stents, but also the need for safer treatments for carotid artery disease.
  • Brazil ranks as the sixthlargest populated country in world and the largest healthcare market in Latin America.
  • With a population over 213 million, Brazil represents an important step toward expanding commercial availability of InspireMD products into new territories.
  • Investors and security holders are urged to read these documents free of charge on the SECs web site at http://www.sec.gov.

Edwards' KONECT RESILIA Aortic Valved Conduit Receives FDA Approval For Complex Aortic Valve Surgeries

Retrieved on: 
Wednesday, July 15, 2020

The KONECT device is the company's latest innovation offering the advanced RESILIA tissue, which incorporates integrity-preservation technology that may help improve valve durability.

Key Points: 
  • The KONECT device is the company's latest innovation offering the advanced RESILIA tissue, which incorporates integrity-preservation technology that may help improve valve durability.
  • The RESILIA tissue technology also allows devices to be stored under dry packaging conditions, facilitating ease of use during patient care.
  • Bicuspid aortic valve disease is the leading cause of aortic aneurysms.
  • Edwards, Edwards Lifesciences, the stylized E logo, KONECT, KONECT RESILIA, Physio, Physio Flex and RESILIA are trademarks of Edwards Lifesciences Corporation.

Expert in Complex Vascular Anomalies Joins Children's Hospital of Philadelphia to Lead Innovative Frontier Program

Retrieved on: 
Monday, July 13, 2020

Dr. Adams comes to CHOP from Boston Children's Hospital, where she has co-led their Vascular Anomalies Center since 2016 and served as an associate professor of pediatrics at Harvard Medical School.

Key Points: 
  • Dr. Adams comes to CHOP from Boston Children's Hospital, where she has co-led their Vascular Anomalies Center since 2016 and served as an associate professor of pediatrics at Harvard Medical School.
  • As a leading expert in the field, Dr. Adams is actively engaged in clinical and translational research on complex vascular anomalies and regularly publishes studies in leading journals on the topic.
  • "Denise Adams has long been recognized as a leader in the field of complex vascular anomalies, and we are delighted she has come to lead CHOP's innovative Frontier Program," said Stephen P. Hunger , MD, Chief of the Division of Oncology at CHOP, which oversees the Complex Vascular Anomalies Program.
  • About Children's Hospital of Philadelphia: Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital.

Balt Receives CE Mark and Performs First-in-Man for the Silk Vista Flow Diverter

Retrieved on: 
Wednesday, July 8, 2020

Balt ( www.balt-corp.com ) announced today it has received CE Mark Approval for its Silk Vista flow diverting stent to treat patients with unruptured intracranial aneurysms, enabling commercialization in over 30 countries in and around the European Union.

Key Points: 
  • Balt ( www.balt-corp.com ) announced today it has received CE Mark Approval for its Silk Vista flow diverting stent to treat patients with unruptured intracranial aneurysms, enabling commercialization in over 30 countries in and around the European Union.
  • The Silk Vista device is designed for predictable and accurate deployment, as well as high visibility under angiography.
  • It joins the lower profile Silk Vista baby flow diverter, which received CE Mark in 2018.
  • The Silk Vista is an exceptional flow diverter, and we believe its elegant design and ease-of-use will lead to its rapid clinical adoption in treating aneurysms.

Medtronic Begins Real-World Post-Market Study of the Valiant Navion Thoracic Stent Graft System in Patients with Thoracic Aortic Dissection

Retrieved on: 
Monday, July 6, 2020

Treatment of aortic dissection is often challenging, especially as patients with fragile aortas have different needs.

Key Points: 
  • Treatment of aortic dissection is often challenging, especially as patients with fragile aortas have different needs.
  • I believe the DISSECT-N study one of the larger prospective aortic dissection repair studies, which includes independent core-lab imaging review will offer critical contemporary insights about TEVAR use in patients with various types of thoracic aortic dissection.
  • An aortic dissection is a serious condition in which the inner layer of the lower aorta is torn, causing the inner and middle layers of the aorta to separate (dissect).
  • Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in approximately 150 countries.

 Endologix Enters into an Agreement with Deerfield Partners to Take the Company Private

Retrieved on: 
Monday, July 6, 2020

Under the terms of the plan filed today, Endologix will become a private company and emerge financially well-equipped to realize the full potential of the most advanced and innovative abdominal aortic aneurysm (AAA) pipeline in the industry.

Key Points: 
  • Under the terms of the plan filed today, Endologix will become a private company and emerge financially well-equipped to realize the full potential of the most advanced and innovative abdominal aortic aneurysm (AAA) pipeline in the industry.
  • Mr. Onopchenko continued: As Endologixs largest lender, Deerfield has demonstrated consistent support for our Companys business strategy and mission to transform aortic care for life.
  • We remain focused on elevating the standard of care for patients suffering from AAA by advancing our strategy and executing our plans with confidence.
  • We firmly believe this is a positive development for our Company and, most importantly, our customers and the patients we proudly serve.