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Clinical-stage company earns FDA approval
The U.S. Food and Drug Administration has approved a venture-backed company’s device to treat high blood pressure.
Ablative Solutions in Kalamazoo said last month that it has received FDA 510(k) clearance for its Peregrine System Infusion Catheter.
The medical device was developed to provide an alternative for the treatment of hypertension and other overactive sympathetic nerve diseases.
The Peregrine System Infusion Catheter delivers diagnostic and therapeutic agents to the nerves surrounding blood vessels, or the perivascular layer. The treatment de-activates nerves encircling the renal artery and subsequently reduces blood pressure, without damaging the artery wall. The company refers to its approach to renal denervation as PeriVascular Renal Denervation, or PVRD.
A clinical evaluation of the therapy using the newly FDA approved Peregrine System Infusion Catheter is anticipated to begin in Europe this year.
“Ablative Solutions is pleased to make the Peregrine System available to clinicians to deliver therapies targeted to the perivascular zone,” said Dr. Vartan Ghazarossian, president and chief operating officer, Ablative Solutions.
Dr. Horst Sievert, director and founder of the Cardiovascular Center Frankfurt, said he’s eager to work with the Ablative Solutions team to explore how to incorporate the Peregrine System into clinical practice.
“Cardiovascular disease can impact so many aspects of patient health,” Sievert said. “As we deepen our scientific understanding of the underlying disease processes, advances in technology can facilitate further insight and can aid in the development of better treatments.”
The center in Frankfurt, Germany is a national and international center for heart and vascular disease diagnosis and treatment.
Left untreated, hypertension is a risk factor for health problems: such as stroke, heart disease, congestive heart failure and obstructive sleep apnea.
Sixty-seven million or one in three adults in the U.S. has high blood pressure, according to the Centers for Disease Control and Prevention.
Ablative Solutions, founded in 2011, completed a Series A financing in June 2012 and a Series B financing in February, for approximately $14.8 million in funding.
The second round of financing was led by BioStar Ventures, Michigan Accelerator Fund and angel investors.