As 2010 comes to a close, the major players in the cardio market are making strategic mergers and acquisitions to position themselves in new markets. Among those just announced are Medtronic’s acquisition of Ardian, St. Jude Medical’s acquisition of AGA Medical, and Boston Scientific’s acquisition of Sadra Medical Inc. In each case, the acquisition has the potential to open new markets for the cardio giants.

Medtronic, Inc. and privately held Ardian Inc recently announced that they have entered into a merger agreement whereby Medtronic will acquire Ardian. Based in Mountain View, CA, Ardian develops catheter-based therapies to treat hypertension and related conditions.

The agreement calls for Medtronic to make an upfront cash payment of $800 million, plus commercial milestones equal to the annual revenue growth through the end of Medtronic’s fiscal year 2015. Medtronic had previously invested in Ardian and currently holds an 11% ownership stake in the company.

 “We view renal denervation for the treatment of uncontrolled hypertension as one of the most exciting growth markets in medical devices,” says Sean Salmon, vice president and general manager of the coronary and peripheral business at Medtronic. “Ardian’s investigational catheter-based treatment for uncontrolled hypertension through renal nerve denervation complements Medtronic’s expertise in catheter design and ablation technologies and augments Medtronic’s interventional therapies.”

Data from a clinical study of Ardian’s flagship product, the Symplicity catheter system, were recently released at the American Heart Association 2010 Scientific Sessions in Chicago and published in The Lancet.  It was reported that patients treated with the Ardian device experienced a 33 mmHg greater reduction in systolic blood pressure at six months (p<0.0001) than the control group. The Symplicity catheter system has received CE mark and Australia TGA listing, but is not approved for sale in the US.

The transaction is expected to close in Medtronic’s third fiscal quarter of 2011 and is subject to customary closing conditions, including US and foreign regulatory clearances.

St. Jude Medical Inc announced that it has successfully completed its acquisition of AGA Medical Holdings Inc. of Plymouth, MN. St. Jude says the acquisition of AGA Medical adds to its portfolio in four new markets: left atrial appendage (LAA) closure, patent foramen ovale (PFO) closure, modification of abnormal peripheral vessels with vascular plugs, and repair of structural heart defects.

"The addition of AGA Medical's strong core business and innovative product pipeline will position St. Jude Medical as the clear leader in the structural heart market and will help expand our product portfolio for interventional radiology," says Daniel J. Starks, chairman, president, and CEO of St. Jude Medical.

The AGA Medical business will become part of the Cardiovascular Division of St. Jude Medical. During the remainder of the fourth quarter of 2010, St. Jude Medical expects $20 million–$25 million in revenue from the AGA Medical business. St. Jude Medical expects the AGA Medical business to grow in double digits in 2011.

In another recent cardio-based merger, Boston Scientific Corp announced the signing of a definitive merger agreement to acquire Sadra Medical Inc, a development-stage company based in Los Gatos, CA. Sadra is developing the first fully repositionable device for percutaneous aortic valve replacement to treat patients with severe aortic stenosis.

The agreement calls for an upfront payment of $225 million plus additional potential payments of up to $225 million upon achievement of specified regulatory and revenue-based milestones through 2016. As a result of St. Jude’s existing 14% ownership of Sadra, the actual upfront cash payment by Boston Scientific will be $193 million plus additional potential milestone payments up to $193 million.

Sadra has recently completed a series of European feasibility studies of its Lotus valve system, which consists of a stent-mounted tissue valve prosthesis and catheter delivery system for guidance and placement of the valve. The low-profile delivery system and introducer sheath are designed to enable accurate positioning, repositioning, and retrieval at any time prior to release of the aortic valve implant.

"The acquisition of Sadra demonstrates Boston Scientific's commitment to providing the most complete and advanced portfolio of less-invasive technology solutions across the entire continuum of cardiovascular care," says Hank Kucheman, executive vice president and group president, Cardiology, Rhythm, and Vascular for Boston Scientific.

Sadra’s president and CEO, Ken Martin, says that both companies believe that the unique ability to reposition and retrieve the Lotus valve provides interventional cardiologists with greater control and allows them to determine whether the valve is accurately placed and working properly prior to completing the procedure.

The acquisition is a critical step in the execution of Boston Scientific’s strategy to realign its portfolio. Percutaneous aortic valve replacement is a fast-growing market within structural heart therapies, and Boston Scientific expects that market to be an important part of its growth plan. Boston Scientific has been a strategic investor in Sadra Medical since 2006.