Globe Newswire06.24.19
BioCardia Inc., a developer of comprehensive solutions for cardiovascular regenerative therapies, has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the AVANCE steerable introducer product family, designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum.
The AVANCE steerable introducer family leverages Morph “DNA” technology, an enhancement of the company’s FDA-cleared Morph steerable introducer, which adds several features that make the devices ideal for use in transseptal procedures and are designed to improve upon commercially-available offerings. The devices are virtually whipless around curves due to their helically arranged pull-wires, enabling greater predictability, stability and control during procedures. They are bidirectional, which further enhances control within the heart. They allow for better catheter conformance to patient anatomy and easier navigation through tortuous anatomy. AVANCE devices also offer a rotating hemostasis side port, which helps reduce physician frustration with tangled fluid lines during a procedure. Three configurations of the device are available.
“We have successfully used our existing Morph products in more than 10,000 clinical procedures to date, including hundreds of cases to deliver cell and gene therapies to the heart,” said BioCardia CEO Peter Altman, Ph.D. “The success of these products led us to further enhance them for the delivery of our investigational CardiAMP and CardiALLO cell therapies, as well as other clinical applications including transseptal procedures.”
Procedures that leverage transseptal delivery include atrial fibrillation ablation, patent foramen ovale (PFO) and atrial septal defect (ASD) repair, percutaneous mitral valve repair, left atrial appendage closure, and percutaneous left ventricular assist device placement, among others. The global transseptal access systems market value is currently estimated at $490 million and is expected to increase at a compound annual growth rate (CAGR) of 10.4 percent from 2017 to 2024.1
BioCardia Inc., headquartered in San Carlos, Calif., is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the company’s biotherapeutic product candidates in clinical development. The company's current products include the Helix Biotherapeutic Delivery System and the Morph steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
Reference
1 Persistence Market Research (2017). “Transseptal Access Systems Market: Global Industry Analysis (2012-2016) and Forecast (2017-2025).” New York, NY. Persistence Market Research Pvt. Ltd.
The AVANCE steerable introducer family leverages Morph “DNA” technology, an enhancement of the company’s FDA-cleared Morph steerable introducer, which adds several features that make the devices ideal for use in transseptal procedures and are designed to improve upon commercially-available offerings. The devices are virtually whipless around curves due to their helically arranged pull-wires, enabling greater predictability, stability and control during procedures. They are bidirectional, which further enhances control within the heart. They allow for better catheter conformance to patient anatomy and easier navigation through tortuous anatomy. AVANCE devices also offer a rotating hemostasis side port, which helps reduce physician frustration with tangled fluid lines during a procedure. Three configurations of the device are available.
“We have successfully used our existing Morph products in more than 10,000 clinical procedures to date, including hundreds of cases to deliver cell and gene therapies to the heart,” said BioCardia CEO Peter Altman, Ph.D. “The success of these products led us to further enhance them for the delivery of our investigational CardiAMP and CardiALLO cell therapies, as well as other clinical applications including transseptal procedures.”
Procedures that leverage transseptal delivery include atrial fibrillation ablation, patent foramen ovale (PFO) and atrial septal defect (ASD) repair, percutaneous mitral valve repair, left atrial appendage closure, and percutaneous left ventricular assist device placement, among others. The global transseptal access systems market value is currently estimated at $490 million and is expected to increase at a compound annual growth rate (CAGR) of 10.4 percent from 2017 to 2024.1
BioCardia Inc., headquartered in San Carlos, Calif., is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the company’s biotherapeutic product candidates in clinical development. The company's current products include the Helix Biotherapeutic Delivery System and the Morph steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
Reference
1 Persistence Market Research (2017). “Transseptal Access Systems Market: Global Industry Analysis (2012-2016) and Forecast (2017-2025).” New York, NY. Persistence Market Research Pvt. Ltd.