Areas of Expertise

Respiratory

Lung volume reduction devices must prove they improve breathing mechanics in hyperinflated COPD lungs where collateral ventilation determines success. Lung sealants face cycling respiratory pressure with every breath. Your sealant must prevent prolonged air leaks after pulmonary resection without causing inflammatory complications.

Our Pulmonary Capabilities

Minimally invasive pulmonary interventions require precision deployment in tight airways. Each device type requires specialized validation approaches. Our bronchoscopy suites and animal models replicate the conditions your device will face clinically.

Our 40 years of bronchoscopic experience provide the safety and effectiveness data FDA reviewers expect. We understand pulmonary mechanics, COPD disease environments, and what makes respiratory testing different.

Complete Respiratory Capabilities

COPD Therapies

Here's the COPD intervention challenge. Your device reduces lung volume to improve breathing mechanics, but effectiveness depends on preventing air from reaching isolated lobes. Collateral ventilation determines whether valves work in hyperinflated, diseased airways. We assess valve deployment accuracy under fluoroscopic guidance and measure sealing integrity. We quantify pulmonary function changes using spirometry and plethysmography. Our protocols address both 510(k) and PMA pathways from one-way valves to coil-based platforms.

Lung Lobe Sealants

Prolonged air leaks after lung surgery create serious complications. Your sealant must seal pleural surfaces under respiratory pressure that cycles with every breath without causing inflammatory complications. We measure seal integrity using standardized air leak quantification protocols under physiological ventilation pressures and assess healing quality at pleural surfaces. Our GLP protocols support submissions across synthetic adhesives, fibrin-based sealants, and hydrogel platforms following ISO 10993 biocompatibility and ASTM surgical sealant standards for thoracic applications.

Ready to Start Your Respiratory Program?

Let's discuss your device and what regulatory pathway makes sense. We'll design a validation strategy that addresses your specific pulmonary device challenges.

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