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WAYNE, Pa.–(BUSINESS WIRE)–

Cagent Vascular, a developer of serration technology for vessel dilatation in cardiovascular disease interventions, announces FDA 510(k) Clearance of its Serranator® PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions.

The Serranator device is the first and only angioplasty balloon FDA Cleared and CE Marked that embeds serration technology into a semi-compliant balloon for treating Peripheral Artery Disease (PAD). It is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion.

The company also recently completed enrollment of its PRELUDE-BTK Study, a prospective, single-arm, multi-center feasibility study to show the safety and efficacy of the device. A total of 49 patients were enrolled. The study is led by Principal Investigator, Dr. Andrew Holden (Auckland, New Zealand). Six centers from Europe and New Zealand are participating in the trial which will include 30-day and 6-month follow up.

“This trial enrolled quickly, which speaks to the enthusiasm for better technology like the Serranator. Treating BTK lesions is a challenge due to the unpredictability we often see with existing balloon therapy such as insufficient lumen gain, vessel dissection and recoil. These arteries are small in diameter, often calcified, with much of the disease located in the distal portion of the leg, making treatment a challenge,” stated Dr. Holden.

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As a first grader in Cape May Courthouse, New Jersey, Mike Maher launched his earliest small business: selling Blow Pops and construction paper.

“Back in the day, colored paper was in high demand and kids always like candy, so I thought it was a great way to subsidize my own love of art and candy,” Maher says, laughing at the memory.

Now, as the CEO of Philly-based Houwzer—the five-year-old real estate brokerage firm that’s disrupted the industry both by employing salaried (versus commissioned) brokers, and committing so deeply to doing good that they’re a certified B Corp—Maher is continuing to recognize needs where others miss them, with a deep sense of empathy, hard work and service.

A sound direction

Long moved by Toms Shoes and Warby Parker, Maher knew there was no practical way to introduce a one-for-one model for homes. But reading Richard Rothstein’s The Color of Law and learning more about the demographic that the United Way and others have dubbed ALICE—asset limited, income constrained employed—prompted his latest venture.

Just this month, Houwzer announced a new, nonprofit RiseUp Fund: Starting in 2021, for every home sold, Houwzer will commit $100 to help provide down payment and closing cost assistance to the underserved.

“The mission will be to accelerate the generational, upward mobility of the underserved through homeownership,” Maher says. “We looked at the resources we had: agents in the field who can probably find off-market deals to acquire property; mortgage advisors who can help clients get their credit in good standing; and so on” and figured out how to maximize both for the greater good.

Over the next 12 months, Houwzer expects to do close to 1,500 transactions in the markets it serves—meaning the fund will have, at a minimum, $150,000. But they’ll also invite sellers, who on average save $15,000 by working with Houwzer, to match that $100; that could bring the projected pot to $300,000. They’ll invite employees to donate around the holidays, potentially raising that pot higher still. And while $300,000 can only go so far, imagine what they can do as the company continues to grow.

Read the full article here.