Insightra Medical

Insightra Medical is a cardiovascular medical device manufacturer headquartered in Clarksville, Tennessee, United States. Founded in 2001 in Irvine, California, as a trading company specializing in cardiovascular products, the company evolved into a manufacturer of intra-aortic balloon pump (IABP) catheters. Its flagship product is the Ultra 7Fr Intra-Aortic Balloon Catheter, a true 7 French catheter designed to provide the benefits of a smaller profile without requiring hardware upgrades. Insightra is one of only three FDA-approved global manufacturers of IABP catheters, according to its official website. The company states that its market shares exceed 40% in many of its historic markets. Insightra focuses exclusively on IABP catheters, positioning itself as a specialist rather than a diversified device maker. Its Ultra 7Fr catheter range includes multiple sizes (20cc, 25cc, 30cc, 35cc, and 40cc) to match patient height, with specialty sizes of 30cc and below designed for smaller patients. The company received CE approval for the Ultra 7Fr IAB Catheter in 2007 and FDA approval in 2009. Insightra Medical Inc. was launched as a manufacturer for IABP catheters in 2007. The company remains privately held and continues to operate from its Clarksville, Tennessee headquarters.

Insightra Medical was founded in 2001 in Irvine, California, as a trading company specializing in cardiovascular products. In 2007, the company received CE approval for its Insightra Ultra 7Fr IAB Catheter, marking a significant milestone in product validation and market access, and launched Insightra Medical Inc. as a manufacturer for IABP catheters. In 2009, the company achieved FDA approval for the Insightra Ultra 7Fr IAB Catheter, solidifying its safety and efficacy for use in the United States. The company later relocated its headquarters to Clarksville, Tennessee, where it operates today. Insightra has focused exclusively on intra-aortic balloon pump catheters, positioning itself as one of only three FDA-approved global manufacturers in this niche. Its Ultra 7Fr catheter is designed to be a true 7Fr device, including the wrapped balloon, allowing it to pass through all 7Fr sheaths and providing a 23% reduction in cross-sectional area compared to a competitive 8Fr catheter. The company reports market shares exceeding 40% in many of its historic markets.

• 2009

  Achieved FDA approval for the Insightra Ultra 7Fr IAB Catheter.

• 2007

  Received CE approval for the Insightra Ultra 7Fr IAB Catheter and launched Insightra Medical Inc. as a manufacturer for IABP catheters.

• 2001

  Founded in Irvine, California, as a trading company specializing in cardiovascular products.

Specialist manufacturer of intra-aortic balloon pump catheters, emphasizing a true 7Fr profile and a singular focus on IABP technology.

• Ultra 7Fr IAB Catheter Kit

  A true 7Fr intra-aortic balloon catheter available in sizes 20cc, 25cc, 30cc, 35cc, and 40cc, designed for temporary support of heart function.

1. 1Insightra Medical - Insightra Medical | Clarksville, TNinsightra.com
2. 2Ultra 7FR IAB Catheter Kit - Insightra Medical | Clarksville, TNinsightra.com
3. 3Insightra Medical (United States) - Wikidatawikidata.org
4. 4Insightra Medical - Insightra Medical | Clarksville, TNinsightra.com