Conformal Medical launches LAA seal study

Conformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients.

Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The 45-patient, single-arm study is designed to evaluate the device’s performance, with an estimated primary completion date of April 2020 and a final completion date of June 2025, according to ClinicalTrials.gov.

The primary outcome is freedom from adverse events at 45 days, defined as all-cause mortality, ischemic stroke, systemic thromboembolism, device- or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention. Secondary outcomes include closure success at 45 days, 6 months and a year and major adverse events measured annually out to five years.

Conformal said the first-in-human use of the LAA seal, in a 63-year-old mountain biker with a history of bleeding episodes with anticoagulation drugs, was performed at the New York-Presbyterian/Columbia University Medical Center in New York City by Dr. Robert Sommer. The patient was discharged the day after his successful implantation on dual anti-platelet therapy per the study’s protocol, the company said.

“First-in-human use marks an important milestone for advancing our approach to stroke prevention,” president & CEO Andy Levine said in prepared remarks. “The experienced team at Columbia is providing valuable insights for optimizing the care of their patients.”

“It is exciting to participate in the first-in-human use of the Conformal device. The form-fitting seal is a promising advance in LAA closure for stroke prevention,” Sommer added.

“Columbia is excited to be the first to introduce this technology to patients,” Interventional Vascular Therapy Center director Dr. Martin Leon said. “I applaud Conformal’s commitment to utilize the FDA’s EFS Program. The ability to participate in early feasibility studies is important for the U.S. device ecosystem as we strive to develop new therapies to better serve our patients.”

Last December Conformal raised $9 million in a Series B round led by Catalyst Health Ventures that included some of its Series A investors.

from MassDevice http://bit.ly/2Gcix8t