SANTA ROSA -- Claret Medical, Inc., a recently formed Santa Rosa-based developer of methods designed to protect against brain embolism during vascular intervention and surgery, received European Union approval today for its Montage System.
This is the second product approval this year for Claret Medical, which incorporated two years ago. The startup has raised $3.38 million of $3.5 million sought in a series A private equity offering, according to an early October regulatory filing.
"The CE Mark approval for the Montage System is an important milestone for Claret, and stems from the incredible dedication of our team to improving patient-care during TAVI (transcatheter aortic valve intervention)," said Randy Lashinski, president and CEO of Claret.
Claret's Montage System operates as a filtration system to protect both carotid arteries at the same time. It is delivered via the radial or brachial arteries and provides complete neuro protection during procedures such as transcatheter aortic valve intervention, thereby removing potential stroke causing material from the body, according to Claret.
"The CE Mark approval for the Montage System is an exciting new step forward to potentially reduce stroke rates in transcatheter aortic valve intervention and other vascular procedures," said Eberhard Grube, director of the Structural Heart Program at University Hospital in Bonn, Germany. "The timing of this innovation could not be better, in that it has the potential to change the way physicians view TAVI in their practice.
Claret's system was "surprisingly elegant and simple to deliver," according to Alexander Abizaid, director of the catheterization laboratory at Institute Dante Pazzanese in Sao Paolo, Brazil.
"We, along with other investigators, were astounded at the volume of debris we found in the filters and were delighted we could provide a solution to help capture and remove this material from the patient's vascular circulation," he said.
The product approvals were supported by data from the clinical trial in Europe, which included 30-day patient followup.
To further study the device in an expanded population, Claret plans to initiate additional controlled clinical trials outside of the United States early next year.
The startup is growing its Santa Rosa base of operations. The company has grown to occupy 3,800 square feet, from 800 square feet of leased space in Core Corporate Center at 3633 Westwind Blvd. near Charles M. Schulz--Sonoma County Airport, according to Jeffrey Wilmore, a partner with commercial real estate brokerage Keegan & Coppin/ONCOR International and co-marketer of the property.
"The ownership has allowed them to start out in a larger space on a month-to-month basis and only charged them for the space that they are using, and they continue to grow," Mr. Wilmore said. "They have now requested a 'first right of offer' on the entire space."
CORRECTION, Nov. 1, 2011: Claret Medical raised $3.38 million of a $3.5 million in a first-round of equity funding started in October, according to an early October regulatory filing. The original story contained incorrect information.