Covidien acquires Sapheon ahead of FDA approval for vein adhesive

The Medtronic-Covidien integration team must be working overtime juggling not only existing products but also those in the deal pipeline. The pair hasn't slowed down at all--between them they have disclosed 5 acquisitions since their own merger announcement in mid-June, three of them this week alone.

The latest came with the Aug. 28 news that Covidien ($COV) is acquiring venous disease treatment company Sapheon. The startup has submitted a PMA to the FDA for its VenaSeal system, which is a medical adhesive designed to close the great saphenous vein in patients with varicose veins and chronic venous insufficiency. The expectation is that it will provide a less invasive and more successful treatment option.

"If left untreated, varicose veins can progress into a chronic and life-threatening condition," Covidien CMO of Vascular Therapies Dr. Mark Turco said in a statement. "The VenaSeal system is a minimally invasive technology, and unlike open surgery and other more invasive procedures, patients are often able to quickly regain their lifestyle."

The system is approved in Canada, Europe and Hong Kong, with more than 2,000 patients having been treated with it. The treatment is performed using a minimally invasive catheter with ultrasound guidance in a physician office or outpatient setting.

The completed U.S. pivotal trial of VenaSeal, dubbed VeCLOSE, is a randomized trial comparing the system to radiofrequency thermal ablation. The trial is of 242 patients at 10 U.S. sites. The company has not released data from it yet.

But in February 2014, Sapheon released one-year data from a European trial of VenaSeal. The single-arm trial involved 70 patients at 7 sites in the U.K., Germany, Denmark and the Netherlands. All treatments were reported as successful, with a closure rate of 93.9% at 12 months (66 patients). None were treated with tumescent anesthesia or postprocedure compression stockings.

VenaSeal will be part of Covidien's Peripheral Vascular business. In its most recent quarterly report, Vascular Therapies' sales were flat compared with the same quarter a year earlier at $417 million. That makes it Covidien's worst performing business. Last week, Covidien acquired another vascular startup, vascular embolization company Reverse Medical, for an undisclosed amount.

"Peripheral Vascular increased sales of chronic venous insufficiency and procedural support products were offset by decreased sales in compression and dialysis and our exit from the renal denervation market," Covidien chairman, president and CEO José Almeida said on a July conference call. "Compression was negatively impacted by a rebate adjustment, which reduced third-quarter sales. Much of this was timing, so we expect both Compression and Peripheral Vascular to improve in the fourth quarter."

Sapheon investors include the Millennium Life Sciences Fund. Most recently, the startup raised $10 million in debt in January and $30 million in a Series B in September 2013. The financial details of the deal weren't disclosed.

Earlier this week, Medtronic ($MDT) said it would acquire hospital services player NGC Medical for $350 million and neuromodulation company Sapiens for $200 million.

- here is the release

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